Bibliography of Studies & Peer Reviewed Papers

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1 Lumenis LightSheer Technology Bibliography of Studies & Reviewed Papers Beauty

2 About Lumenis Lumenis is a global leader in the field of minimally-invasive clinical solutions for the Surgical, Ophthalmology and Aesthetic markets, and is a world-renowned expert in developing and commercializing innovative energy-based technologies, including Laser, Intense Pulsed Light (IPL) and Radio-Frequency (RF). For nearly 50 years, Lumenis ground-breaking products have redefined medical treatments and have set numerous technological and clinical gold-standards. Lumenis has successfully created solutions for previously untreatable conditions, as well as designed advanced technologies that have revolutionized existing treatment methods in each and every one of the verticals we operate in. Our drive for innovation stems from an uncompromising commitment to improving the health and well-being of our patients; addressing new and growing needs of aging populations; and in offering medical professionals cutting-edge solutions that fit seamlessly into the health-economics environment of the 21st century. The world over, we bring Energy to Healthcare. 2 Lumenis LightSheer Technology - Bibliography of Studies & Reviewed Papers

3 Table of Contents Laser hair removal 5 s 5 papers 15 Asian skin hair removal 18 Dark skin hair removal 19 Vascular Lesions and Pigmented Lesions 22 Lumenis LightSheer Technology - Bibliography of Studies & Reviewed Papers 3

4 Abbreviations LHR WL DL IPL FU Laser Hair Wave Length Diode Laser Intense Pulsed Light Follow Up 4 Lumenis LightSheer Technology - Bibliography of Studies & Reviewed Papers

5 Bibliography STUDY TITLE TOPIC AUTHORS TITLE MAIN TOPICSAUTHORS MAIN ARTICLE RESEARCH CONCLUSIONS SITES PUBLICATION YEAR YEAR ABSTRACT 1 Safety and Long term efficacy comparison between Light- Sheer XC and IPL A. Klein, S. Steinert, W. Baeumler, M. Landthaler, P. Babilas Photoepilation with a Diode Laser vs. Intense Pulsed Light (IPL): A Randomized, Intra-Patient Left-to-Right Trial Treatment with LightSheer XC is more effective (after 12 months follow up) than IPL treatment. LightSheer XC treatment time is faster than IPL Br J Dermatol Jun;168(6): BACKGROUND: Safe and efficient options for removing unwanted hair are in great demand. Laser devices and intense pulsed light (IPL) sources are the most commonly used treatment modalities. Yet, only a few randomized controlled trials (RCTs) comparing laser and IPL devices are available, and RCTs with long-term results are missing in the literature. OBJECTIVES: To compare the safety and long-term efficacy of diode lasers (DL) and IPL sources for axillary hair removal, we conducted an intra-patient, left-to-right, assessor-blinded and controlled trial. METHODS: IPL (Ellipse Flex PPT, Danish Dermatological Development, Hoersholm, Denmark; λem = nm) and DL (LightSheer XC system, Lumenis Inc., Santa Clara, CA, USA; λem = 800 nm) treatments were evaluated in 30 study participants (skin type II-III) with unwanted axillary hair growth. Six treatments with each device were carried out in 4-week intervals. Final assessment was conducted 12 months after the last treatment by means of hair counts using close-up photographs. Primary endpoint was reduction in hair growth, analysed on an intentionto-treat and last- observation-carried-forward basis (n=30), and secondary endpoints were patient- rated efficacy, treatment-related pain, adverse effects and treatment duration. RESULTS: Both devices significantly reduced hair counts. Mean reductions from baseline (3 and 12 months after the last treatment) were 59.7% and 69.2% for DL and 42.4% and 52.7% for IPL treatment (p < 0.01). DL treatment induced significant more pain (3.7 ± 2.1 (DL) vs. 1.6 ± 1.4 (IPL); p < 0.01; visual analogue scale) but could be conducted faster (33.1 ± 3.8 s (DL) vs ± 5.0 s (IPL); p < 0.01). No severe side effects were observed for either therapy. CONCLUSION: Both DL and IPL treatment is highly effective, long-lasting and safe. DL was found to be more effective than IPL treatment. DL treatment was more painful but less time-consuming than IPL therapy. Lumenis LightSheer Technology - Bibliography of Studies & Reviewed Papers 5

6 STUDY TITLE TOPIC AUTHORS TITLE MAIN TOPICSAUTHORS MAIN ARTICLE RESEARCH CONCLUSIONS SITES PUBLICATION YEAR YEAR ABSTRACT 2 Long-Term Clinical Evaluation of a 800- nm Long- Pulsed Diode Laser with a Large Spot Size and Vacuum- Assisted Suction for Hair Omar A. Ibrahimi, MD, PHD, and Suzanne L. Kilmer, MD Long term clinical evaluation of LightSheer Duet with HS handpiece 15 month follow up for treatment with LightSheer Duet HS is safe and effective- 15 month follow up Significant changes in hair thickness and color 40% patients reporting 0-2 pain level during treatment Dermatol Surg 2012; BACKGROUND: The long-pulsed diode ( nm) laser is one of the most commonly used and effec- tive lasers for hair removal. Limitations of currently available devices include a small treatment spot size, treatment-associated pain, and the need for skin cooling. OBJECTIVE: To evaluate the long-term hair reduction capabilities of a longpulsed diode laser with a large spot size and vacuum assisted suction. METHODS: Thirty-five subjects were enrolled in a prospective, self-controlled, single-center study of axillary hair removal. The study consisted of three treatments using a long-pulsed diode laser with a large spot size and vacuumassisted suction at 4- to 6-week intervals with follow-up visits 6 and 15 months after the last treatment. Hair clearance was quantified using macro haircount photographs taken at baseline and at 6- and 15-month follow-up visits. Changes in hair thickness and color, levels of treatment-associated pain, and adverse events were additional study endpoints. RESULTS: There was statistically significant hair clearance at the 6 (54%) and 15-month (42%) follow-up visits. Remaining hairs were thinner and lighter at the 15-month follow-up visit, and the majority of subjects reported feeling up to mild to moderate pain during treatment without the use of pretreatment anesthesia or skin cooling. CONCLUSION: A long-pulsed diode laser with a large spot size and vacuumassisted suction is safe and effective for long-term hair removal. This is the largest prospective study to evaluate long-term hair removal and the first to quantify decreases in hair thickness and darkness with treatment. 3 Low- Fluence VS. Standard Fluence Hair : A Contralateral Control Non- Inferiority Study Shlomit Halachmi & Moshe Lapidoth HS and ET deliver similar effective results Patients treated with hs handpiece were 82% more likely to seek additional treatment with hs handpiece After 5 treatments minimal to no difference were visible between ET and hs handpieces 83% would continue treatment with other body areas after using HS and ET handpieces Journal of Cosmetic and Laser Therapy, 2012; 14: INTRODUCTION: Laser hair removal at lower fluences, delivered under certain conditions, may retain the efficacy of high-fluence lasers while improving tolerability. We performed a pilot study comparing the efficacy, safety and tolerability of laser hair removal using traditional settings compared to lower fluences, delivered from a larger handpiece and under vacuum. MATERIAL AND METHODS: Fourteen healthy participants underwent 5 axillary hair removal treatments with an 800 nm diode laser at 1-month intervals, with follow-up 1 and 3 months after the 5th treatment. In all patients, one side was treated with standard parameters using a 9 x 9 mm chilled tip and gel, while the contralateral side was treated using a 22 x 35 mm vacuumassisted handpiece at fluences up to 12 J/cm 2. Follow-up assessments were performed after each treatment and at each follow-up visit, and included photography and questionnaires. RESULTS: Eleven participants completed the study and follow-up. All experienced significant hair removal in all treated areas. At the 3-month follow-up visit, the high-fluence and low-fluence treated axillae demonstrated comparable hair reduction. Participants found the lower fluence treatments to be more tolerable. No adverse events were reported. CONCLUSION: Lower fluence diode laser, delivered under conditions of vacuum and using larger spot sizes, can provide significant hair reduction. 6 Lumenis LightSheer Technology - Bibliography of Studies & Reviewed Papers

7 STUDY TITLE TOPIC AUTHORS TITLE MAIN TOPICSAUTHORS MAIN ARTICLE RESEARCH CONCLUSIONS SITES PUBLICATION YEAR YEAR ABSTRACT 4 Laser Hair Omar A. Fundamentals of fective laser treatments Therapy, Vol. to target and destroy hair follicles, thereby leading to hair removal. Today, laser Guidelines for safe and ef- Dermatologic 2011 The extended theory of selective photothermolysis enables the laser surgeon Ibrahimi*,, Mathew hair 24, 2011, hair removal (LHR) is the most commonly requested cosmetic procedure in M. Avram, 2-patients the world and is routinely performed by dermatologists, other physicians, and C. William selection non-physician personnel with variable efficacy. The ideal candidate for LHR is Hanke, Principles of fair skinned with dark terminal hair; however, LHR can today be successfully Suzanne laser safety performed in all skin types. Knowledge of hair follicle anatomy and physiology, L. Kilmer Introducton proper patient selection and preoperative preparation, principles of laser & R. Rox Laser tissue safety, familiarity with the various laser/light devices, and a thorough Anderson interaction understanding of laser-tissue interactions are vital to optimizing treatment efficacy while minimizing complications and side effects. 5 Evaluation of the Vacuum- Assisted Handpiece Compared with the Sapphire- Cooled Handpiece of the 800- nm Diode Laser System for the Use of Hair and Reduction Yang Xia 1, Rachael Moore 1, Sunghun Cho 2, & Edward V. Ross 1 Comparison of HS and ET handpieces using duet system Treatment with vacuum assisted handpieces is faster and more comfortable Thermal damage to the hair follicle is greater with sapphire cooled handpieces Measurement using biopsies from the skin proved the thermal damage to the hair follicle while using HS and ET handpieces J Cosmet Laser Ther Dec;12(6): BACKGROUND: A handpiece with a mm treatment window that uses vacuum technology has been designed for the diode laser system. Vacuum suction stretches the skin and brings the hair follicle closer to the surface with the intent to damage the hair follicle at a lower surface fluence. The objective of this study was to compare the degree of follicular thermal damage between the sapphire-cooled smaller handpiece at a higher fluence versus the larger vacuum-assisted handpiece at a lower fluence. METHODS: Five male patients with Fitzpatrick skin types I-IV were enrolled in the study. Three test spots on the right back were treated with the vacuumassisted laser handpiece at a setting of J/cm², and 61-ms pulse duration. Three test spots on the left back were treated with the sapphirecooled handpiece with a setting of J/cm² and a pulse duration of ms. A punch biopsy was obtained from one treated area for each handpiece type. The biopsies were sectioned horizontally and examined for the degree of thermal damage to the hair follicle at the level of the isthmus and the bulb. Immediate treatment response, pain score, and total treatment time were recorded. RESULTS: Biopsies from the skin treated with the sapphire-cooled handpiece and the vacuum-assisted handpiece showed the mean hair follicle diameter was µm (SE [standard error] 41.7) and µm (SE 17.1), respectively. The mean thermal damage diameter to hair diameter ratio was 0.91 (SE 0.10) and 0.72 (SE 0.12), respectively. The mean immediate treatment response, the mean pain severity, and the mean total treatment time were all lower for the vacuum-assisted handpiece. CONCLUSION: Treatment with the vacuum-assisted handpiece is faster and has a tendency to be more comfortable. Thermal damage to the hair follicle was greater with the sapphire-cooled handpiece. Lumenis LightSheer Technology - Bibliography of Studies & Reviewed Papers 7

8 STUDY TITLE TOPIC AUTHORS TITLE MAIN TOPICSAUTHORS MAIN ARTICLE RESEARCH CONCLUSIONS SITES PUBLICATION YEAR YEAR ABSTRACT 6 Within- H. Cameron Diode vs Hair reduction with diode Lasers Med Sci 2008 BACKGROUND: Excessive facial hair in women can cause significant & S. H. IPL, Efficacy (2008) 23:393 Ibbotson & R. for hair 397 S. Dawe & J. removal is Ferguson & higher with H. Moseley diode laser Patient Right- Left Blinded Comparison of Diode (810 nm) Laser Therapy and Intense Pulsed Light Therapy for Hair laser is more effective than using IPL 6 weeks after 3 treatments despite slightly higher pain course, laser was preferred by more than 50% of the patients psychological distress. A variety of treatment methods are available, including lasers and, more recently, intense pulsed light (IPL) sources. There are very few studies comparing laser and IPL devices. PURPOSE AND METHODS: The purpose of our study was to compare a laser diode device with an IPL, using a within-patient, right-left, assessorblinded, controlled, study design. Hair counts were made, using coded close-up photographs. Treatments were carried out on three occasions at 6-week intervals, and a final assessment was made 6 weeks following the third treatment. Patient self- assessment was also included. RESULTS: Nine women were recruited, and seven completed the study. Average hair counts in a 16 cm 2 area before and after treatment were, respectively, 42.4 and 10.4 (laser), 38.1 and 20.4 (IPL), 45.3 and 44.7 (control). Both laser and IPL reduced the hair count substantially; laser vs control was significant at P=0.028, but IPL vs control had P=0.13, suggesting that more subjects or more treatments were required if statistical significance were to be achieved. Despite subjecting the patients to higher pain scores and more inflammation, laser was preferred by five patients; two preferred IPL and one had no preference. 7 Lasers and Light Michael H. Gold, MD Market review Sources For the of Unwanted Hair Not applicable Clinics in Dermatology 25, The long-term removal of unwanted hair has become one of the most common and popular cosmetic laser treatments being performed around the world. This manuscript will review a variety of lasers and light sources that have been and are currently being used for epilation of the skin. All of the lasers and light systems currently available do work for long-term hair removal; it is the responsibility of the treating clinician to understand the varying technologies and what the limits of each device is and, most importantly, to be able to handle any untoward effects that might arise during the coarse of treatment. Then, hair removal can be successful for both the patient and the physician using their particular medical device. 8 Pain Inhibition with Pneumatic Skin Flattening (PSF) in Permanent Diode Laser Hair Malcolm KE Comparison of pain level with and without high speed technology HGH seed tech considerably removed the pain in hair removal compared with non high speed tech Energy density may be increased while using HS technology to increase efficacy Journal of Cosmetic and Laser Therapy 9: INTRODUCTION: Permanent laser-based hair removal is normally associated with acute pain. Pneumatic skin flattening (PSF) is a new technology which activates tactile and pressure skin receptors to naturally block the transmission of pain to the brain during laser-based aesthetic treatments (gate theory of pain control). OBJECTIVE: Efficacy and pain reduction was evaluated compared with controls for the treatment of hair removal with PSF and a high-energy diode laser (LightSheer, Lumenis). METHODS: Ten patients were treated for hair removal with the LightSheer at energy densities of J/cm 2. Each patient was treated with PSF and without PSF (control sites). Pain was evaluated on a 1 10 scale level. Hair growth was compared 1 month following treatment. RESULTS: Pain reduction was achieved with the PSF chamber in 9/10 patients. Hair removal efficacy was preserved. CONCLUSION: The PSF technology considerably reduces pain in hair removal with high-power diode lasers. Treatment efficacy is preserved with identical energy densities. Moreover, energy density may be increased without pain or side effects, resulting in the potential to enhance efficacy. Analgesic creams are no longer required. 8 Lumenis LightSheer Technology - Bibliography of Studies & Reviewed Papers

9 STUDY TITLE TOPIC AUTHORS TITLE MAIN TOPICSAUTHORS MAIN ARTICLE RESEARCH CONCLUSIONS SITES PUBLICATION YEAR YEAR ABSTRACT Not applicable 9 Biological J Lepselter 1 Market and Clinical Aspects in Laser Hair and M Elman 2 Review (Comparison of ruby Nd:YAG alexandrite lasers (J Dermatol Treat (2004) 15: 72 83) 2004 INTRODUCTION: In the past century, unwanted hair has been traditionally treated with multitudes of techniques that were found to be slow, tedious, painful, impractical, and resulted in poor long-term efficacy. Consequently, there has been a public demand for a novel, rapid, reliable, safe, and affordable hair removal technique. In the last decade, laser and light-based technology for hair removal became one of the fastest growing procedures in modern cosmetic dermatology. OBJECTIVE: To discuss the latest scientific and clinical issues in the field of photoepilation as evolved in the past decade: hair biology, laser physics and skin optics, technology and clinical experience. RESULTS: From substantial clinical experience, it becomes apparent that in the ideal subject with fair skin and dark hair, a single treatment can reduce hair by 10 40%; three treatments by 30 70%; and repeated treatments by as much as 90%. These results persist for as long as 12 months. Diffuse and perifollicular cutaneous erythema and pigmentary changes are the most common adverse side effects. Most complications are generally temporary. CONCLUSIONS: Photoepilation, when properly used, offers clear advantages when compared with older, traditional techniques. Although an ever-increasing number of published studies have confirmed the safety and short and longterm efficacy of photoepilation, the technology still has limits and risks. 10 Safe and Valeria B. Safety and Proven efficacy of Lumenis Inc This study examined hair reduction in eleven tanned women and one tanned Campos, MD efficacy of LightSheer in tanned LightSheer patients at specific settings in 10 patients Proper settings of ET is 30 (with J/cm 2 and 100 ms skin types III to IV Effective Long- Term Hair Reduction in Tanned Patients Using an 800 nm Diode Laser man (with Fitzpatrick Skin Types III to IV) using the 800 nm LightSheer Diode Laser System at our clinic in Jundiai, Brazil. The patients were treated with fluences ranging from 30 to 45 J/cm 2 at pulse durations of 30 and 100 ms and a pulse frequency of 0.5 Hz. Long-term hair reduction was achieved with all tested fluences and pulse durations, with hair regrowth ranging from 23% at one month post-treatment to 73% at the twelve-month follow-up period. Although the difference was not statistically significant, hair regrowth was slightly higher in sites treated at 100 ms at all time periods. With a fluence of 30 J/cm 2 and a pulse duration of 30 ms, a single treatment site on each of three patients developed either hypopigmentation (1 site) or hyperpigmentation (2 sites). At 30 J/cm 2 and 100 ms, no pigmentary change or any other sign of epidermal injury was observed in any patient treated. This study suggests that the LightSheer Diode Laser System provides both safe and effective long-term reduction of unwanted hair in tanned patients with a fluence of 30 J/cm 2 and a pulse width of 100 ms. Lumenis LightSheer Technology - Bibliography of Studies & Reviewed Papers 9

10 STUDY TITLE TOPIC AUTHORS TITLE MAIN TOPICSAUTHORS MAIN ARTICLE RESEARCH CONCLUSIONS SITES PUBLICATION YEAR YEAR ABSTRACT 11 Importance of Cutaneous Cooling During Photothermal Epilation: Kurt G. Klavuhn, PhD, and David Green, MD Contact cooling efficacy and safety for hair removal (et Chill Tip hand piece) Theoretical and Practical Considerations Treatment using Chill Tip with high fluence did not have any permanent damage to epidermis or dermal injury Lasers Surg Med. 2002;31(2): BACKGROUND AND OBJECTIVES: Sapphire contact cooling is widely used to prevent non-specific epidermal injury from occurring during selective laser treatment of unwanted hair and vascular lesions. This small study was performed to examine the clinical response of the skin to 800-nm laser irradiation with varying extent of cutaneous sapphire contact cooling. Observed clinical responses are compared to those predicted by theoretical analysis in an attempt to construct a more complete picture of sapphire contact cooling and its role in preventing non-targeted tissue devitalization during laser treatment of the skin using a wavelength, pulse duration, and radiant exposure commonly used for laser hair removal. STUDY DESIGN/MATERIALS AND METHODS: Three subjects each received a total of three pulses of laser light (800 nm) of equal radiant exposure (60 J/cm( 2 )), pulse duration (30 msec), and spot size (9 mm x 9 mm), but with varying extent of cutaneous cooling. One site was pre-cooled and heat-sinked with a chilled (5 degrees C) sapphire window in contact with the skin; another site was heat-sinked only with a room-temperature (20 degrees C) sapphire window in contact with the skin; and a third site received no pre-cooling or heat-sinking. Each site was examined immediately after treatment and at intervals throughout a 3-month period. The thermal response of the tissue was calculated in each case using a Monte Carlo model for light transport in multilayered tissues coupled with an axisymmetric finite-difference heat diffusion model. Thermal injury was modeled as a first-order kinetic rate process using an Arrhenius expression. RESULTS: In all three subjects, the sites that were pre-cooled and heatsinked showed no evidence of epidermal or dermal devitalization. The three sites that were heat-sinked only had a few patches of perifollicular epidermal devitalization and subsequent desquamation without any permanent epidermal or dermal injury, as would be evidenced by pigmentary alteration or textural change. In each subject, the site that received no pre-cooling or heat-sinking sustained epidermal and dermal devitalization, appearing as ulceration and resulting in sustained erythema and textural alteration. Clinical responses predicted by theoretical analysis agree with the clinical observations and show that the dominant effect of sapphire contact cooling for pulse durations of 30 msec or less is the reduction of fluence within the epidermis resulting from index matching at the skin surface. CONCLUSIONS: The results of this small study suggest that by judiciously selecting the laser pulse duration and pre-cooling and heat-sinking the epidermis in a manner that provides index matching and compression of the skin, epidermal damage can be avoided while administering the highest, most effective radiant exposures. 10 Lumenis LightSheer Technology - Bibliography of Studies & Reviewed Papers

11 STUDY TITLE TOPIC AUTHORS TITLE MAIN TOPICSAUTHORS MAIN ARTICLE RESEARCH CONCLUSIONS SITES PUBLICATION YEAR YEAR ABSTRACT 12 Illumination Kurt G. Comparison Geometry: The Importance of Laser Klavuhn, PhD of Large spot size vs. Small spot size Beam Spatial Characteristics 9mm square spot size provide the most effective target depth (1-3mm) and fluence Sapphire contact enables the safe use of higher more effective fluence levels Spot size smaller than 8mm may be unsafe Spot sizes higher than 9mm will have less fluence per square cm Beam profile is very important as flat beam has 54% more fluence than a gaussian beam Lumenis, Inc BACKGROUND: Laser hair removal is becoming an increasingly popular alternative to traditional methods such as shaving, waxing, depilatory creams, or electrolysis. Numerous laser systems are currently available offering different methods of illuminating the treatment area. The fluence distribution within the tissue and, thus, the treatment efficacy depends upon the illumination geometry, namely the index matching at the skin surface, the incident spot size, and the energy distribution within the incident beam. OBJECTIVE: To analyze and discuss the various aspects of illumination geometry in the context of laser hair removal. METHODS: Detailed calculations of the influence of each aspect on the energy distribution during the treatment pulse were performed. CONCLUSION: Calculations using typical skin parameters for wavelengths of nm show that matching of the index of refraction at the skin surface by illumination of the treatment area through sapphire in contact with the skin, for example, alone (i.e. aside from the beneficial heat-sinking effects) can reduce the epidermal heating up to 30% by minimizing the amount of internally reflected photons at the skin surface. Thus, by providing favorable index matching at the skin surface, sapphire contact enables the safe use of higher, more effective fluence levels. The calculations also show that a 10-mm diameter spot size (or 9-mm square) produces a fluence level at target depths of 1 3mm equal to 73 88% (depending on depth) of the fluence level at the same depths produced by an infinitely wide beam of equal incident fluence. This means that little additional penetration is achieved with larger spot sizes. In addition, most commercial laser hair removal systems that provide larger spot sizes (> 14 mm in diameter) are unable to produce adequate fluence at the larger beam sizes to achieve the same level of efficacy of systems with 8 14mm diameter beams. In contrast, a 5-mm diameter spot size produces a fluence level at target depths of 1 3mm of only 37 52% (depending on depth) that of an infinitely wide beam of equal incident fluence. Because of the epidermal heating resulting from the rela- tively high fluence level at the skin surface, the penetration of smaller diameter beams can not be made to match that of broader beams by simply increasing the incident fluence. Thus, laser hair removal systems that provide smaller spot sizes (< 8 mm in diameter) may be unable to safely produce the desired therapeutic effect. Calculations using typical skin parameters for wavelengths of nm show that, for equivalent epidermal heating, up to 54% higher fluence can be applied using a beam with a flat energy distribution profile versus a gaussian profile, resulting in significantly deeper and broader penetration of the beam. For this reason, a laser hair removal systems with a predominantly flat beam profile will be more effective and induce fewer complications than a laser with a largely gaussian profile (i.e. with a central hot spot ). 13 Laser hair removal Mark M Hamilton, Market overview update M.D., Steven H. Dayan, M.D., Paul J. Carniol, M.D., F.A.C.S. Facial Plast Surg Aug;17(3): Laser hair removal has made possible the permanent reduction of unwanted hair. However, this technology remains far from perfect. Many advances have occurred in the past several years to improve laser hair removal, including lengthening pulse widths and adding mechanisms to cool the skin during treatment. These advances have improved results and broadened the scope of patients who are candidates for this procedure. This reviews the latest advances as well as the various laser hair removal systems currently available. Lumenis LightSheer Technology - Bibliography of Studies & Reviewed Papers 11

12 STUDY TITLE TOPIC AUTHORS TITLE MAIN TOPICSAUTHORS MAIN ARTICLE RESEARCH CONCLUSIONS SITES PUBLICATION YEAR YEAR ABSTRACT 14 Coverage Rate: The Influence of Laser Parameters on Kurt G. Klavuhn, PhD Advantages of using large spot size vs using small spot size Treatment Time Large spot size enables bigger area to be treated with each pulse Small spot size might leave missed areas Lumenis, Inc BACKGROUND: Laser hair removal is becoming an increasingly popular alternative to traditional methods such as shaving, waxing, depilatory creams, or electrolysis. Numerous laser systems are currently available offering different maximum fluence levels, spot sizes, and pulse repetition frequencies, each of which influence the amount of time it takes to treat a given area. OBJECTIVE: To analyze and discuss the influence of various laser parameters on coverage rate. METHODS: The influence of various laser parameters, including spot size and shape, and repetition frequency, on coverage rate and their impact on available fluence and pulse duration were analyzed. Theoretical coverage rates for commercially available hair removal systems were calculated and compared. CONCLUSION: For laser hair removal systems with square, rectangular, or hexagonal beam shapes, the coverage rate is equal to the area of the treatment spot times the pulse repetition frequency. Treatment with a circular beam requires a minimum of 17% overlap in order to cover the entire treatment area. In general, large spot sizes (i.e. > 14 mm in diameter) enable more area to be treated with each laser pulse; however, at least J/cm 2 at nm ( J/cm 2 at 1064nm) must be available to effect clinically significant long- term hair reduction. Treatment with small spot sizes (i.e. < 8 mm in diameter) may result in inadvertent missed areas as a result of the reduced penetration of the beam. Scanning systems without contact cooling are limited in the amount of fluence that can be used as a result of increased risk of epidermal injury. All Lumenis LightSheer Diode Laser Systems are effective at the appropriate treatment fluences. The LightSheer ET has a faster coverage rate (up to times) than all major hair removal systems at fluences of 25J/cm 2 and higher. The new Coherent LightSheer XC Diode Laser System with a mm beam and repetition rates up to 2 Hz provides the fastest coverage rate of all commercially available hair removal systems. 15 Hair Christine C. Dierickx, MD Market review by Lasers and Intense Pulsed Light Sources Semin Cutan Med Surg Dec;19(4): Unwanted pigmented hair is a common problem for many patients. Traditional methods of hair removal have included shaving, bleaching, plucking, waxing, use of chemical depilatories, and electrolysis. These techniques have been limited by their pain, inconvenience, and poor long-term efficacy. Only electrolysis has offered the potential for permanent hair removal. However, the technique is tedious, highly operator-dependent, and impractical for the treatment of large numbers of hairs. Recently, a number of lasers and other light sources have been developed specifically to target hair follicles. These include ruby, alexandrite, diode, and Nd:YAG lasers and an intense pulsed light source. These devices offer the potential for rapid treatment of large areas and long-lasting hair removal. This explains the mechanisms of using light to remove hair, examines the attributes of specific laser systems, and explains the importance of patient selection and treatment protocol for the various systems in order to provide a safe and effective treatment. 12 Lumenis LightSheer Technology - Bibliography of Studies & Reviewed Papers

13 STUDY TITLE TOPIC AUTHORS TITLE MAIN TOPICSAUTHORS MAIN ARTICLE RESEARCH CONCLUSIONS SITES PUBLICATION YEAR YEAR ABSTRACT 16 Hair Valeria B. 800 nm removal with an 800-nm pulsed diode laser Campos 1, MD, Christine C. Dierickx, MD, William A. Farinelli, BS, Tai-Yuan D. Lin, MD, Woraphong Manuskiatti, MD, and R. Rox Anderson, MD diode laser is effective and safe for hair removal Higher fluences and multiple treatments produce long term efficacy J Am Acad Dermatol Sep;43(3): BACKGROUND AND OBJECTIVE: Laser hair removal is a relatively new procedure. Our purpose was to study the efficacy and safety of a high-power, pulsed diode laser array for removing unwanted hair. METHODS: A total of 38 subjects were treated with a prototype of the 800-nm diode laser system. Fluences ranging from 10 to 40 J/cm( 2 ) (mean, 33.4 J/cm( 2 )) were used and 1 to 4 treatments (mean, 2.7) were performed. Evaluation of hair loss was performed at least 4 months after the last treatment (mean, 8.7 months) by a blinded assessment of clinical photographs. RESULTS: A total of 59% of the subjects had only sparse hair regrowth at the final follow-up. Higher fluences and multiple treatments produced greater longterm efficacy. Transient pigmentary changes occurred in 29% of the subjects and were more common in darker skin types IV to VI (P =. 047). CONCLUSION: The 800-nm diode laser is an efficient and safe technique for hair reduction. Adverse pigmentary effects occur, but are transient. 17 Prospective Wendy W. 800 nm study of hair reduction by diode laser (800 nm) with long-term Lou 1, MD, Adelle T. Quintata 1, MD, Roy G. Geronemus 1,2, MD, and Melanie C. diode laser chill tip cooled provides long-lasting results in patients follow-up Grossman, MD 3 50 patient 8 tested sites 20 month follow up shows permanent hair loss of 65-75% 800 nm laser diode is safe and effective with variable pulse duration Dermatol Surg May;26(5): BACKGROUND: Multiple laser systems are available for the purpose of hair removal. OBJECTIVE: The purpose of this study was to determine the safety and longterm efficacy of the 800 nm, pulsed diode laser at reducing hair count. METHODS: Fifty volunteers, primarily Fitzpatrick skin types II and III, with dark brown or black hair, were treated with a diode laser (800 nm, J/ cm 2, 5-30 msec, 9 mm 9 mm, 5 degrees C chilled handpiece). Each subject had eight treatment sites at varying fluences and pulse durations, as well as a varying number of treatments and pulses. Hair counts were obtained at each site at baseline, 1, 3, 6, 9, and an average of 20 months after treatment. RESULTS: After one treatment, hair regrowths ranged from 22 to 31% at the 1-month follow-up visit, then remained stable between 65 and 75% from the 3-month to the averaged 20-month follow-up. After two treatments there were relatively longer growth delays, with hair regrowths plateauing beginning at 6 months after treatment and ranging from 47 to 66% for the remainder of the follow-up evaluations. Side effects were limited to pigmentary changes, transient in subjects with skin types II and III. CONCLUSIONS: This 800 nm diode laser with a chilled sapphire tip and variable pulse duration is safe and effective for long-term hair reduction in individuals with skin types II and III. Lumenis LightSheer Technology - Bibliography of Studies & Reviewed Papers 13

14 STUDY TITLE TOPIC AUTHORS TITLE MAIN TOPICSAUTHORS MAIN ARTICLE RESEARCH CONCLUSIONS SITES PUBLICATION YEAR YEAR ABSTRACT 18 Reduction Tai-Yuan Diode laser is more effective than ruby of Regrowing Hair Shaft Size and Pigmentation After Ruby and Diode Laser Treatment David Lin, Christine C. Dierickx, Valeria B. Campos, William A. Farinelli, Joshua Rosenthal, R. Rox Anderson With ruby laser 85% responded to treatment, with diode laser 92% responded to treatment With diode laser the results always show thinner and lighter hair, whereas with ruby laser the results dont always show Archives for Dermatological Research (Impact Factor: 2.71). 01/2000; 292(2-3): Laser pulses which selectively damage pigmented hair follicles are a useful treatment for hypertrichosis. Clinically, regrowing hairs are often thinner and lighter after treatment. In this study, hair shaft diameter and optical transmission (700 nm) were measured before and after ruby (694 nm) and diode (800 nm) laser irradiation. Hair was collected from 47 and 41 subjects treated with ruby (0.3 ms and 3 ms) and diode (10-20 ms) lasers, respectively. Responders were defined as subjects with significant long-term hair loss as determined by hair counts at 9 and/or 12 months after treatment. In ruby laser responders (34/47), regrowing hairs were significantly both thinner (decreased diameter) and lighter (increased transmission). In nonresponders (13/47), regrowing hairs were lighter, but not thinner. The regrowing hair shaft absorption coefficient (as calculated assuming Beer s law) was significantly decreased by 0.3 ms ruby laser treatment, but was not changed by 3 ms ruby laser or diode laser treatment. After diode laser treatment, 38 of the 41 subjects were responders and regrowing hairs were both thinner and lighter. These results show that laser treatments can affect structural recovery (size of hair), follicular pigmentation (hair absorption coefficient), or both. Regrowth of thinner hair (decreased shaft diameter) occurs in conjunction with actual loss of hair. After long pulses (3 ms ruby; diode), regrowing hair was thinner and also lighter to an extent related to the decrease in hair diameter. In contrast, short ruby laser pulses (0.3 ms) appeared to be capable of inhibiting follicular pigmentation per se, in addition to affecting the hair diameter. This may account for the complete regrowth of lighter hair in nonresponders treated with 0.3 ms pulses. Laser-induced reduction in hair diameter and/or pigmentation are both long-term responses which confer cosmetic benefits in addition to actual hair loss. 19 Pilonidal Sinus Disease Treated by Depilation Using an 800 nm Diode Laser and Review of the Literature Anthony V. Benedetto, DO, FACP,Alan T. Lewis, MD Diode laser is effective in the treatment of pilonidal sinus disease The 800 nm diode laser may be an effective tool in the treatment of pilonidal sinus disease Dermatol Surg May;31(5): BACKGROUND: Pilonidal sinus disease is a debilitating, disfiguring chronic ailment that is often resistant to therapy. Its etiology and treatment remain in question. OBJECTIVE: To assess the efficacy of an 800 nm diode laser in the treatment of recalcitrant pilonidal sinus disease. METHODS: Two patients with recalcitrant pilonidal sinus disease were treated in the lower back, buttocks, and perigluteal cleft area with an 800 nm diode laser with a spot size of 9 x 9 mm, fluences of 30 to 48 J/cm 2, and pulse widths of 15 to 24 milliseconds. RESULTS: Long-term relief of pilonidal sinus disease was produced with as few as two treatments 2 months apart to as many as six treatments over a 2-year period. With each successive treatment, fewer pulses were needed and the interval between treatments increased. CONCLUSION: The 800 nm diode laser may be an effective tool in the treatment of pilonidal sinus disease. By eliminating the source of hair and hair fragments that course along the surface of the lower back and buttocks, interruption of the etiologic source for pilonidal sinus disease can be accomplished. 14 Lumenis LightSheer Technology - Bibliography of Studies & Reviewed Papers

15 STUDY TITLE TOPIC AUTHORS TITLE MAIN TOPICSAUTHORS MAIN ARTICLE RESEARCH CONCLUSIONS SITES PUBLICATION YEAR YEAR ABSTRACT 20 Efficacy of Diode Laser for Treating Acne Keloidalis Nuchae Girish K. Shah Succesful treatment of Acne Keloidalis Nuchae with Diode lasers 90-95% clearence of acne after only 4 treatments with diode laser Laser diode treatment prevented reccuring of the acne Indian J Dermatol Venereol Leprol Jan- Feb;71(1): Acne keloidalis nuchae is usually treated with oral antibiotics, local antiseptics or intralesional steroids but with limited success. I assessed the efficacy of diode laser for treating the inflammatory and keloidal papules of acne keloidalis nuchae in two cases. The lesions in both the cases showed about 90 to 95% clearance after 4 treatment sessions at one to one and half month intervals. No new lesions were observed during the follow up period of six months after the last laser treatment. Thus, after clearing bacterial infection, laser hair epilation can be used as the first line of therapy for treating papules of acne keloidalis nuchae. This is the first attempt at treating acne keloidalis nuchae with a diode laser. 21 Laser Hair : Efficiency, Efficacy, and Comfort Are Key Girish (Gilly) Munavalli, MD LightSheer Duet LightSheer Duet : the power of two easily interchangeable handpieces for various anatomic sites and fast hair removal Patient selection and management are key for succesful hair removal Lumenis Supplement to Practical Dermatology Laser hair removal is one of the top three most popular aesthetic services requested by patients in the US, and is also among the highest-reimbursed procedures. Many established and growing dermatology practices may find that laser hair removal is an attractive addition to their service menu. Of course, due to patient considerations, laser hair removal is not a good fit for every practice (see the side- bar for some important considerations). Yet, some practices that would likely benefit from the inclusion of laser hair removal have been reluctant to embrace the service due to perceived limitations of the laser systems themselves. The LightSheer Duet system (Lumenis) is a two-in-one system that has streamlined laser hair removal treatment in my practice and allows for a patient-friendly, practice-enhancing experience. paper 22 Optimizing the Efficacy and Comfort of Laser Hair Treatment Mary P Lupo MD Comparison of LS Desire with palomar vectus Articles review See also youtube.com/ watch?v=ed 8VnSuKu88 Compared to Palomar Vectus: 1. LS Desire has 40 % shorter treatment time. 2. LS Desire is more than 40% less painful. 3. Efficacy of Vectus is questionable ((Lowery et al.), Efficacy of LS desire is proven throughout this Compendium. Compared to other sytems (ND:YAG) LS Desire is shorter less painful and has an Efficacy that is as good as other technologies. Lumenis, Inc 2013 INTRODUCTION: Physicians who wish to maintain or increase their share of the laser hair removal market must find ways to differentiate themselves from competitors and to offer a treatment that is optimized for efficacy and comfort. While a practitioner s skill and expertise play a large role in the treatment experience, the choice of laser hair removal system also has significant impact on patient satisfaction in both the near and longer term. Data indicate that the two LHR areas with which physicians are most concerned are patient pain and efficacy. METHOD: Here we compare the data describing the efficacy, pain, and treatment time for the LightSheer DESIRE TM (Lumenis, Inc.) and Vectus TM (Palomar Medical Technologies, Inc.). CONCLUSIONS: 1.mean Treatment time in various areas is:6 minutes with LS Desire- and 9.6 minutes with Palomar Vectus (on 15 patients) 2. Pain: Average VAS scores were significantly lower for the LSHS (2.2 ± 0.5) than for the Vectus large spot size (3.9 ± 0.5) (p <.01) paper Lumenis LightSheer Technology - Bibliography of Studies & Reviewed Papers 15

16 STUDY TITLE TOPIC AUTHORS TITLE MAIN TOPICSAUTHORS MAIN ARTICLE RESEARCH CONCLUSIONS SITES PUBLICATION YEAR YEAR ABSTRACT 23 Optimizing Earnings with Laser Hair Doris Day, MD Comparison of Candela GentleLase to LS Duet Candela Gentelase is inferior to LS duet in parameters of: pain, treatment time, and profitability Lumenis, Inc 2013 INTRODUCTION: The Market. Laser hair removal is one of the top five nonsurgical cosmetic procedures in the United States, with over 1.2 million procedures performed in It can appear that there is a dermatologists office on every corner offering this service, however, from 1997 to 2012 there was almost a 500% increase in the total number of minimally-invasive procedures such as injectable and laser procedures, and permanent hair removal still has the potential to be very profitable METHOD: LS Duet and Candela GentleLase: Comparison of earning per patient. Comparison of treatment time. CONCLUSIONS: Treatment time with GentleLase is about 4 times longer than with LS Duet. Earning per patient is almost twice for LS Duet then with the GentleLase. Patient comfort is better due to the uneccesity of gel for treatment with HIT technology. 87% of patients describe the treatment with HIT as virtually painless. Paper 24 Laser Hair with an 800nm Atif Kazmi, MD Safety and efficacy of women II to VI Diode Laser - A Retrospective Study of 1000 Women with Skin Types II to VI Reduction of 70-85% of hair within 4-5 treatments Lumenis Inc This retrospective study examined hair removal using the LightSheer Diode Laser System for the first 1000 women (with Fitzpatrick Skin Types II to VI) treated at the Laserex Skin & Cosmology Clinic in Lahore, Pakistan. Overall, the women achieved satisfactory results within four or five treatment sessions, with apparent hair reduction ranging from 70% to 80% in women treated over their entire face and neck, up to 95% in women treated for hair on their legs, arms, or bikini line. Minor scabbing or pigmentation changes were observed in a small percentage of women treated, but these adverse effects were transient in nature and resolved after treatment was stopped. This study demonstrates that the LightSheer Diode Laser System provides both safe and effective removal of unwanted hair in patients with Fitzpatrick Skin Types II to VI. Paper 25 Effective, Christine Safety and efficacy of dialed laser treatments Permanent Hair Reduction Using a Pulsed, High- Power Diode Laser C. Dierickx, MD; R. Rox Anderson, MD; Valeria B. Campos, MD; Melanie C. Grossman, MD Effective laser fluence in various treatment numbers and various pulses numbers Lumenis Inc A solid-state, 800 nm pulsed near-infrared diode laser1 was studied for permanent hair reduction. The effect of laser fluence (energy per unit area), single vs. multiple treatments, and single vs. multiple pulses were determined in different skin types (Fitzpatrick s type I through VI). Paper 16 Lumenis LightSheer Technology - Bibliography of Studies & Reviewed Papers

17 STUDY TITLE TOPIC AUTHORS TITLE MAIN TOPICSAUTHORS MAIN ARTICLE RESEARCH CONCLUSIONS SITES PUBLICATION YEAR YEAR ABSTRACT 26 Laser Hair : Scientific principles and Christine C. Dierickx, M.D. LightSheer dialed laser permanent hair reduction Practical Aspects 89% permanent hair reduction in patients Hair reduction is a function of the fluence properties Laser energy ommition does not damage epidermis Lumenis Inc The use of lasers for hair removal has been studied for a number of years. In this procedure, laser light is absorbed by melanin in the hair shaft, damaging the follicular epithelium. A clinical study evaluated the use of the LightSheer Diode Laser for hair removal. Of 92 patients, all had temporary hair loss and 89% had permanent hair reduction. Regrowing hairs were shown to be thinner and lighter than previously. Extensive clinical use of this high-power, pulsed diode laser has resulted in recommendations for patient selection and proper use of the laser. Appropriate fluence settings have been shown to cause permanent hair reduction without damaging the epidermis, regardless of skin type. Paper 27 Epidermal Protection: A Comparative Analysis of Sapphire Contact and Cryogen Spray Kurt G. Klavuhn, PhD Sapphire contact cooling (Chill Tip) is significantly more effective than cryogen spray cooling Cooling Sapphire cooling is protecting the epidermis from damage The efficacy for the contact cooling is twice of the cryogen cooling Sapphire contact cooling provides maximum comfort for patients Lumenis, Inc BACKGROUND: Laser hair removal is becoming an increasingly popular alternative to traditional methods such as shaving, waxing, depilatory creams, or electrolysis. Numerous laser systems are currently available offering different methods for protecting the epidermis from thermal injury during treatment. OBJECTIVE: To analyze the effectiveness of sapphire contact and cryogen spray cooling in the context of laser hair removal. METHODS: A detailed analysis of each technique including calculations of the skin s thermal response to each cooling method before, during, and after the treatment pulse was per- formed. CONCLUSION: Sapphire contact cooling is significantly more effective than cryogen spray cooling in protecting the epidermis from unwanted thermal damage during laser hair removal treatment. Calculations show that a system using sapphire contact cooling with a 30ms pulse duration is approximately two times more effective in protecting the epidermis than cryogen cooling with 3ms pulses given equal target heating. Efficient precooling of the epidermis, compression of the skin, and concurrent heat-sinking of the epidermis with a chilled sapphire window in conjunction with a longer treatment pulse duration result in superior epidermal protection. The concurrent heat-sinking of the epidermis in conjunction with a longer treatment pulse duration is the largest contributing factor reducing the temperature rise of the epidermis by over 40%. In addition to being more effective, sapphire contact cooling provides protection of the epidermis at significantly lower cost, with no risk of freezing and maximum comfort for the patient by cooling before, during, and after the treatment pulse. Paper 28 Use of the Rube J. Wide range LightSheer Pardo, MD, Diode Laser Ph.D., Judy study of LightSheer System for Hair Reduction: Safety and Efficacy Fahey, RN on variety of patients shows both safety and efficacy in a Large Series of Treatments 250 sites 144 patients skin types II-V 84% showed good to excellent results More than 96% were satisfied with the treatment Lumenis Inc An 800 nm high-power, long-pulsed diode laser with contact cooling provides safe and effective reduction of pigmented hair in patients with a variety of skin types. This paper presents the safety and efficacy results of 800 treatments performed on 250 sites in 144 patients with Fitzpatrick skin types II-V. Over 84% of sites showed a good or excellent response following the second and subsequent treatments. Treatment responses were similar for all skin types treated, with an excellent safety profile. Side effects were noted in only two of the 800 treatments and were transient in nature. Patients were extremely or moderately satisfied with over 96% of their treatments. Paper Lumenis LightSheer Technology - Bibliography of Studies & Reviewed Papers 17