Clinical Book Primelase

Prime performance. Prime results.



Primelase - Clinical Book Dear physician, We would like to thank you for your interest in Primelase Excellence, a powerful diode platform for hair removal, skin rejuvenation, acne, vascular lesions and pigmentary lesions. Primelase has extensive trajectory and countless success stories after being in the market for 10 years and it remains as a top line choice. In this digital book you will find extensive information of our technology, results and clinical evidence. We are sure this information will help you understand the benefits of having Primelase in your practice and we remain at your disposal for any other consultations you may have. Primelase Team

Science Laser mechanism of action for permanent hair reduction. P H O T O T H E R M O LY S I S 1. Photo Absorption of the light (photons) by a determined chromophore (hemoglobin, melanin, water). 2. Thermo Transformation of the absorbed light into heat. 3 Lysis Destruction of the cells, which are the target due to the high temperature they are exposed. Laser hair removal process How does laser hair removal work? The laser heats up the hair by the absorption of light by the melanin. The surrounding cells heat up by thermal diffusion. How to achieve permanent hair removal? By reaching more than 60ºC in the hair, the growth cells (bulb cells) and the stem cells (bulge cells). If the temperature in the hair shaft is not high enough, the growth cells and the stem cells are not damaged and the hair will regrow. The heating should produce irreversible thermal damage in all the hair structures. What are the limitations? Epidermis: Temperature < 43ºC Pain: increases with the pulse duration.

Primelase - Clinical Book Doctors advantages Primelase is not only hair removal, it’s a platform that serves for skin rejuvenation, acne, pigmented lesions and vascular lesions attracting patients with different needs to your practice. Primelase versatility due to it’s different wavelengths as well as different spot sizes allows practitioners to treat patients with safety & efficacy. High power diode with a long lifetime guarantee that you can maximize the device use and your ROI. Static mode and Dynamic mode brings máximum flexibility for patients, allows to choose between speed and safety bearing in mind the sensitivity that a patient may experience or safety for different skin phototypes for a always efficanceous and safety treatment. Patients advantages The Primelase provide a safety treatment for hair removal for all phototypes, from phototype I to phototype VI. The Primelase treatment can be perform all year long. Primelase Crystal Freeze makes treatment more confortable for the patient. Due to Primelase power patients can have same results vs other systems in fewer sessions. Fewer sesión for same results translate in treatment affordability for patients. Great results in fewer time due to bigger spotsizes with efficacy.

Primelase benefits Ultra short pulse Proprietary of Primelase, our Ultra Short Pulses are shorter and the rise time faster and more stable than other laser diodes in the market. Uniform distribution of the energy during the entire pulse. Without overshoots and very stable. No overlapping pulses. More effective and safer treatments when using ultra short pulses Primelase Standard Diodes Instant popcorn effect. Insufficient hair heating. Effective heating of Significant heating of the skin without the hear. noticeable hair heating. MAXIMUM EFFICACY LESS EFFICACY AND MORE DISCOMFORT Better results, more comfort and increase profitability for all skin types

Primelase - Clinical Book Homogeneous spot shape Top hat and square shape is much more effective for laser hair removal than gaussian or round spot shapes. Perfect overlapping between shots > faster and more precise and efficacious treatments. Uniform heating provide better results with increa- sed safety and comfort for the patient. Warranty of faster and homogenous results Static mode 1 HZ, 2HZ and 3HZ Dynamic mode (in motion) 5HZ, 10HZ The “gold standard” for hair removal. 3Hz at all fluencies (competitive systems First sessions with large areas and high speed decreased with fluence increase). hair density. Auto mode: offers always the shortest pulse duration for the selected fluence. Higher skin types on a safer way. Maximum flexibility for all patients. Always efficacious and comfortable. Anytime of the year + tanned skin and Safety, efficacy and treatment speed. very stable. Wavelength: Scattering Shorter wavelengths have more scattering and they penetrate less into the skin. Longer wavelengths have less scattering and they penetrate deeper into the skin. Depth of penetration

Primelase wavelengths Benefits of Primelase Blend (1060nm + 940nm + 810nm) for dark skin types Excellent results for skin types I, II, III y IV, and fine hair. Better results for skin types V y VI compared with other wavelengths. High durability and high power by using 810nm rather than 755nm. High profitability thanks to high frequency > speed of treatment and improved lifetime. More comfortable and safer for all skin types. Increased safety, deeper penetration and enhanced heating of the hair thanks to the 940nm contribution. L XXL XL L Alex 755 nm Diode 810 nm 3.600W – 20x9. 4800W – 20x9 30x9 20x15 30x17. The greatest power with diode Speed & Efficacy. Shorter pulses. technology. Skin types I to IV. Same wavelength of the Alexandrite Treatments during the entire with the advantages year, including summer months. of diode lasers. Treatments of tanned skin (dynamic Lighter skin types, I-III, thin hair. mode). Maximum efficacy on residual hair.

Primelase - Clinical Book Primelase offers 4 different spot sizes in order to obtain the best efficacy with each wavelength: 30x17 mm (810nm). Faster treatments. 30x9 mm (810nm & Blend). Best compromise between efficacy and speed. 20x15 mm (810nm) Best compromise between efficacy and speed. Square shape. 20x9 mm (755nm, 810nm & Blend). Higher efficacy. 4x3 mm (1060nm). Indicated for vascular treatments. XL L S Blend (1060+940+810 nm) Yag 1060 nm 4000W – 20x9 30x9. 2000W – 4x3. All skin types, specially III-VI. Indicated in vascular Treatments during the treatments. entire year, including Skin types I to IV. Treatments during the summer months. entire year, including Treatments of tanned skin (dynamic summer months. mode). Allow higher fluences with maximum safety for skin types IV-VI.

Before & After Hair Removal BEFORE AFTER 6 SESSIONS Be Af Zoom in ter fore

Hair Removal Primelase - Clinical Book BEFORE AFTER 3 SESSIONS Be Af Zoom in Courtesy of Sinclair Medical Department ter fore

Before & After Hair Removal BEFORE AFTER 7 SESSIONS Be Af Zoom in ter fore

Hair Removal Primelase - Clinical Book BEFORE AFTER 7 SESSIONS Be Af Zoom in Courtesy of Sinclair Medical Department ter fore

Before & After Hair Removal BEFORE AFTER 4 SESSIONS Be Af Zoom in ter fore

Hair Removal Primelase - Clinical Book BEFORE AFTER 3 SESSIONS Be Af Zoom in Courtesy of Sinclair Medical Department ter fore

Before & After Hair Removal BEFORE AFTER 1 SESSION Be Af Zoom in ter fore

Skin rejuvenation Primelase - Clinical Book BEFORE AFTER Be Af Zoom in Courtesy of Sinclair Medical Department ter fore

Before & After Skin rejuvenation BEFORE AFTER Be Af Zoom in ter fore

Acne clearance Primelase - Clinical Book BEFORE AFTER Be Af Zoom in Courtesy of Sinclair Medical Department ter fore

Before & After Acne clearance BEFORE AFTER Be Af Zoom in ter fore

Acne clearance Primelase - Clinical Book BEFORE AFTER Be Af Zoom in Courtesy of Sinclair Medical Department ter fore

Before & After Vascular lesion BEFORE AFTER Be Af Zoom in ter fore

Primelase - Clinical Book Vascular lesion BEFORE AFTER Be Af Zoom in Courtesy of Sinclair Medical Department ter fore

Before & After Vascular lesion BEFORE AFTER Be Af Zoom in ter fore

Vascular lesion Primelase - Clinical Book BEFORE AFTER Be Af Zoom in Courtesy of Sinclair Medical Department ter fore

Before & After Vascular lesion BEFORE AFTER Be Af Zoom in ter fore

Primelase - Clinical Book Vascular lesion BEFORE AFTER Be Af Zoom in Courtesy of Sinclair Medical Department ter fore

Scientific Brief Treatment of lentigines by a novel hIgh-power diode laser at 755nm: a case report Iranian Journal of Dermatology, 2018; 21: 98-101. Gabriel Buendía Bordera, Jorge Gaviria Parada, Maribel Martí Giménez, María de los Llanos Pérez, Júlia Oliva Morel, Gregorio Viera Mármol. KE Y TAKE AWAY • A patient with 40-year-old woman of Caucasian origin and IV Fitzpatrick phototype, who presented with solar lentigines of different sizes and clear edges, was treated with primelase 755nm, 21ms and 25J/cm2 fluence. • Initially, the darkening of the lesion occurred, followed by the appearance of a scab, which remitted 10 days after. • The feasibility of removing pigmented lesions using a 755nm high-power diode laser was demonstrated, specifically solar lentigines. It is an effective and safe procedure and marks the appearance of a new therapeutic alternative for this indication. Efficacy and Safety of high-power Diode Laser at 1060nm for skin rejuvenation treatment Eurasian Journal of Medical Investigation, 2019; 3(3):241-244. Gabriel Buendía Bordera, Maribel Martí Giménez, Maria De los Llanos Pérez, Júlia Oliva Morell, Gregorio Viera-Mármol, Caridad Elena Morales MuneraMorel, Gregorio Viera Mármol. KE Y TAKE AWAY • The use of a high-power 1060nm diode laser is a novel method for skin rejuvenation that could emulate the efficacy and safety of the long-pulse 1064nm Nd:YAG solid-state laser, while keeping the advantages of semiconductor lasers: pulse quality, contact cooling and low maintenance. • The patient was a 43-year-old Caucasian woman with Fitzpatrick Skin Phototype II, presenting facial sagginess and nasogenian fold. A 4-sessions treatment (1 every 6 weeks) was performed by a High Power Diode Laser at 1060nm. • The laser parameters were: 10J/cm2 fluence and 400ms pulse duration. A 4mm distancer was placed on the hand-piece. An infrared thermometer was used to ensure that the skin reached 42ºC. • 3D fringe projection measurements of the wrinkle confirmed a 18.8% volume improvement, a 15.5% reduction of the maximum depth and a 22% average depth decrease of the wrinkle. • Nasogenian fold 3D measurements showed an 18.5% volume improvement, a 34.9% reduction of the maximum depth and a 12.6% average depth decrease, as well as a 9.3% improvement of the skin roughness. • The high-power diode laser at 1060nm is a new and more approachable alternative that has demonstrated to be effective and safe for facial rejuvenation.

Primelase - Clinical Book Use of high-power Diode Laser at 1060nm for the treatment of vascular lesions Journal of Vascular Surgery, 2019; 5(4); 415-418. Gabriel Buendía Bordera, Jorge Gaviria Parada, Maribel Martí Giménez, María de los Llanos Pérez, Júlia Oliva Morel, Gregorio Viera Mármol. KE Y TAKE AWAY • The use of a high-power 1060nm diode laser is a novel method for vascular lesions that could emulate the efficacy and safety of the long-pulse 1064nm Nd:YAG solid-state laser, while keeping the advantages of semiconductor lasers: pulse quality, contact cooling and low maintenance. • The use of 1060nm wavelength light emitted from a high-power diode laser is a novel method for the removal of vascular lesions. • Two Caucasian women with Fitzpatrick skin phototype II, who had various vascular lesions, were treated with a 1060nm high-power diode laser, applying a fluence of 120J/cm2 and a single pulse duration of 74 milliseconds. • Immediate results were that the cherry angiomas became dark and a scab was formed (that remitted 2 weeks after treatment); the telangiectasias and venulectasias disappeared immediately. • This technology has reported effective and safe results for removing different types of vascular lesions in the two patients treated. Side effects were those expected for this technique. Treatment of Acne by a novel high power diode laser at 1060nm: a case report Eurasian Journal of Medical Investigation, 2019; 3(4):333-335. Gabriel Buendía Bordera, Caridad Elena Morales Munera, Maria De los Llanos Pérez, Gregorio Viera-Mármol. KE Y TAKE AWAY • The use of a high-power 1060nm diode laser is a novel method for the treatment of acne. Although 1064nm Nd: YAG solid-state lasers have been one of the most frequently used light sources due to its array of pulse durations, it requires additional expensive maintenance over time. • The patient was a 19-year-old Caucasian woman with Fitzpatrick Phototype II skin, presenting inflammatory facial acne lesions. A 5 sessions treatment (one per week) was performed with a 1060nm diode laser applicator. • The laser parameters were: 40J/cm2 fluence and 30 ms pulse duration. • The patient experienced no pain during the procedures but did experience mild discomfort in some areas. No side effects occurred. • Skin brightness (caused by sebum secretion) was found to decrease a 27.9% and redness a 17.9%. • The 1060nm long-pulsed diode laser is effective and safe for treating acne marks the appearance of a new, more approachable and affordable alternative for this indication.

Scientific Brief A novel high-power 1060-nm diode laser for the treatment of vascular malformations: a pilot study using dermoscopy to evaluate clinical end points Lasers in Medical Science. 2020. https://doi.org/10.1007/ s10103-020-03068-1. Fernandez-Nieto, D., Jimenez-Cauhe, J., Ortega-Quijano, Boixeda, P. KE Y TAKE AWAY • The 1060-nm high-power diode laser appears to be a safe and effective alternative for the treatment of vascular malformations that could emulate the longpulse 1064nm Nd:YAG solid-state laser, while keeping the advantages of semiconductor lasers: pulse quality, contact cooling and low maintenance. • 12 patients affected by vascular malformations were treated with a 1060-nm high-power diode laser, applying a fluence of 25 to 35J/cm2, 1 to 4 stacks with 250ms delay. Epidermal cooling was provided with contact cooling by the 10 °C cold sapphire tip of the applicator, 3 s before shooting. All the patients received topical anesthetic (lidocaine and prilocaine) 1 h before the procedure. New 2,000W, 1,060nm diode laser with a spot size of 4x3mm for vascular lesion treatments International Research Journal of Pharmacy and Medical Sciences (IRJPMS). 2022.5(2): 19-25. Reyna Vargas Lamas, Gregorio Viera Mármol, Gabriela Vergara Vallejo, Marta Castillejos Pallàs, José Antonio Ferrández Martínez, Carmen Cano Ochoa, Jorge Villena García. KE Y TAKE AWAY • Diode laser technology with a similar wavelength to 1,064nm Nd:YAG solid-state lasers has been used to treat vascular lesions. This wavelength range is believed to provide the best compromise between efficacy and safety for different skin types. Diode laser technology has several advantages over solid-state lasers, such as its lower cost; smaller size; superior durability; the absence of optics, pumping lamps and crystals; minimal maintenance requirements; and its quick and easy installation. However, the main limitation is that diodes on the market cannot reach high fluences with short pulse durations. • 17 subjects with vascular lesions and skin types II to V according to the Fitzpatrick scale, involving a total of 78 treatment areas and 248 procedures, were treated in a prospective study on clinical efficacy and safety. The laser parameters included: static mode with fluences between 100 and 225J/cm2, pulse widths between 9 and 50ms and a frequency of 1Hz; as well as dynamic mode with fluences between 15 and 45J/cm2, pulse widths between 3 and 4ms and a frequency of 10Hz. The number of sessions and the parameters were defined according to the lesion and its progress during the treatment. • The new 4x3mm, 1,060nm, 2,000W diode laser has demonstrated very good results for the elimination of a wide range of vascular lesions in facial and corporal areas, offering a comfortable, safe and fast treatment for subjects with vascular lesions and skin types II to V.

Primelase - Clinical Book New 3D in Silico Model of Hair and Skin Heating During Laser Hair Removal International Research Journal of Pharmacy and Medical Sciences. 2019; 3(1):15-24. Gregorio Viera Mármol, Jorge Villena. KE Y TAKE AWAY • There is not any clinical way to measure or evalua- te the internal temperature of hair and skin during hair removal treatment and thus to determine the efficacy and safety. • In this study, a new 3D numerical multiphysics model has been developed to simulate the hair removal pro- cess, using laser pulses of 755 nm, 810 nm and 1064 nm and with different power from 400 to 4000W. • The simulations reveal that the best results are obtai- ned with laser pulses which are shorter than the ther- mal relaxation time of the hair (4–50 ms). • The higher the fluence, the greater the damage to the hair structure will be. However, the fluence is limited by the absorption of the epidermis which is dependent on the skin type and the laser wavelength. • For low numbered skin types (I and II), high fluence can be used for all wavelengths, from 755 nm to 1060 nm. However, for high numbered skin types, the maximum fluence for each wavelength is limited by the epidermal absorption, especially for the 755 nm wavelength. Best results are obtained with 1060 nm laser diodes for high skin types since they allow the use of a higher fluence without damaging the skin. • The model developed in this study can be used to gain a better understanding of the laser hair removal process, to conduct clinical studies, develop better and safer devices, and to assist clinicians in the selection of parameters for achieving optimal and safe results during hair removal procedures. Comparative Clinical Study and Thermal Modelling of Photoepilation of Thin Hair by Primelase Excellence 810nm and Blend and Soprano XL 810nm International Research Journal of Pharmacy and Medical Sciences. 2019; 3(1):53-60. Carlos Fajardo Urdiales (1), Ana-Belén Rodríguez Casimiro (1) Jorge Villena (2) Maria de los Llanos Pérez (2) Juan Salvador Vicente Solà (2) Gregorio Viera Mármol (2). 1: Clínica Fajardo, Málaga, Spain 2: Cocoon Medical S.L.U., Barcelona, Spain. KE Y TAKE AWAY • 10 subjects were recruited for this study, of both se- xes with skin types II to IV and with axillary hair not previously treated. • Subjects received three treatments spaced over a month and a half: - Primelase Laser Diode on the left armpit (Skin type II and III with 810nm; Skin type IV with Blend). - Soprano Laser Diode (all skin type with 810nm) on the right armpit. • After 3 treatments, the average hair reduction was 53% with Soprano XL and 69% with Primelase Excellence, which represents a 55% greater efficacy with Primelase.

Scientific Brief Comparative Clinical Study and Thermal Modelling of Photoepilation of Thin Hair by Primelase Excellence 810nm and Blend and Soprano XL 810nm International Research Journal of Pharmacy and Medical Sciences. 2019; 3(1):53-60. Carlos Fajardo Urdiales (1), Ana-Belén Rodríguez Casimiro (1) Jorge Villena (2) Maria de los Llanos Pérez (2) Juan Salvador Vicente Solà (2) Gregorio Viera Mármol (2). 1: Clínica Fajardo, Málaga, Spain - 2: Cocoon Medical S.L.U., Barcelona, Spain. KE Y TAKE AWAY • Investigators observed significantly better depilation in the left armpit (Primelase) than in the right armpit (Soprano) and patient satisfaction were also signifi- cantly more satisfied subjects with depilation in the left armpit (Primelase). • In the first two sessions, due to the long duration of its pulses, Soprano generates more pain than Primelase. • In the third session when the hair is thinned, the long pulses of Soprano do not allow heating of re- sidual hair as much as Primelase, since such a long pulse (40ms) is much longer than the TRT of residual hair (less than 10ms). • In contrast, Primelase high power does allow it to heat residual hair more than Soprano equipment, which produces a greater perception of pain. • The thermal damage simulation of STANDARD HAIR for the left armpit (Primelase) was 7% greater than for the right armpit (Soprano). • The thermal damage simulation of RESIDUAL HAIR for the left armpit (Primelase) was 65% greater than for the right armpit (Soprano). • The greater efficacy of the Primelase equipment with residual hair suggests that the number of sessions needed to achieve permanent hair removal will be smaller. • Blend applicator was safe and effective for hair re- moval from dark skin: high fluences were used without side effects and with a percentage of hair reduction similar to those obtained with lower skin types. Efficacy of Thin Hair Removal by Dynamic Application of 810-nm Diode Lasers: In Silico and Clinical Comparative Study of Two Laser Powers: 4,800W and 1,000W International Research Journal of Pharmacy and Medical Sciences. 2020; 4(1):15-23. Mariano Vélez González (1) Gregorio Viera Mármol (2) Jorge Villena (2). 1: Centro Medico Ronefor. Barcelona, Spain - 2: Cocoon Medical S.L.U., Barcelona, Spain. KE Y TAKE AWAY • 14 subjects were recruited for this study, females with skin types II to III, with thin hair, brown and black, on arms, legs and buttocks not previously treated.

Primelase - Clinical Book KE Y TAKE AWAY • Subjects received three treatments in dynamic mode, spaced over two months: - 4,800W (Primelase Excellence) on the left side. - 1,000W on the right. • After 3 treatments, the average hair reduction was 55% with 1,000W and 64% with 4,800W. • In addition, only mild and temporal side effects were reported, without remarkable differences between both sides. • The results predicted by the simulation were corrobo- rated by the clinical data. • Using the shortest pulse duration, simulations re- vealed an average improvement of 15% with original-size hair, and a significantly greater improvement of 21% with the residual thinned hair. • This is the first time a study of this kind has been per- formed. There are no other studies that have assessed the dynamic application of the photoepilation tech- nique using different laser powers, and hence different laser pulse durations, with special attention paid to the removal of thin hair. • This clinical study corroborates the results of the simulations which predicted that the dynamic mode of the 4,800W diode laser device would be more effective than other systems with less power, especially for thin hair, while also being comfortable and safe. • Accordingly, fewer sessions are needed to achieve total hair removal with a high-power diode laser of 4,800 W. New 4.800W, 810 nm Diode Laser with a Spot Size of 20x15 mm for Permanent Hair Removal: Pilot Clinical Study International Research Journal of Pharmacy and Medical Sciences. 2021; 4(6):4-7. Gregorio Viera Mármol (1) Jose Antonio Ferrández Martínez (1) Gabriela Vergara Vallejo (1) Carmen Cano Ochoa (1) Jorge Villena (1) Reyna Vargas Lamas (1). 1: Clinical and Scientific Department at Cocoon Medical, Barcelona, Spain. KE Y TAKE AWAY • Treatments were performed in eight body areas including chest, arms and legs, using both static and dynamic application modes in a single hair removal session. • The treatment parameters used were: dynamic mode with 3-7 ms of pulse duration, 1-10 J/ cm2 of fluence and 10 Hz of frequency, and static mode with 3-32 ms, 5-40 J/cm2 and 1-3 Hz. • Fast sessions, with an average of 5.5 minutes, were carried out according to the area treated. • A high level of hair reduction (74.4%) was achieved in only one session. • No side effects were reported, except for perifollicular edema just after treatment, which is considered a desirable end point. • The application of high power and short pulses ensures a pulse duration lower than the thermal relaxation time of the hair, allowing permanent hair removal to be achieved in fewer sessions.

Scientific Brief New 4.800W, 810 nm Diode Laser with a Spot Size of 20x15 mm for Permanent Hair Removal: Pilot Clinical Study International Research Journal of Pharmacy and Medical Sciences. 2021; 4(6):4-7. Gregorio Viera Mármol (1) Jose Antonio Ferrández Martínez (1) Gabriela Vergara Vallejo (1) Carmen Cano Ochoa (1) Jorge Villena (1) Reyna Vargas Lamas (1). 1: Clinical and Scientific Department at Cocoon Medical, Barcelona, Spain. KE Y TAKE AWAY • The new design of the applicator tip, with a spot size of 3 cm2 (20x15 mm), allows treatments on large and small areas without the need to change the applicator, improving the overlap between each shot and achieving permanent hair reduction in a shorter treatment time. • The new design provides a safe and comfortable treatment due to its optimized sapphire-crystal cooling system. Using blend wavelengths in order to improve the safety and efficacy of laser hair removal Journal of Cosmetic Dermatology. 2021;00:1-4. Yehonatan Noyman MD (1,2) Assi Levi MD (1,2) Ofer Reiter MD (1,2) Moshe Lapidoth MD MPH (1,2). 1: Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel - 2: Laser Unit, Division of Dermatology, Rabin Medical Center, Petach Tikva, Israel. KE Y TAKE AWAY • A total of 18 patients classified with Fitzpatrick pho- totype scale III and IV received hair removal treatments in 49 areas including the back, abdomen, chest, shoulders, lower extremities, armpits, and groin. • Laser parameters including fluence of 14-20J/cm2, pulse duration of 7-30ms, and frequency rate of 2-3Hz in a spot size 20x9mm applicator were used. • Patients underwent 4 sessions with the Blend wave- length (810, 940, and 1060nm) followed by 1–3 ses- sions with a single-wavelength (755nm), with an inter- val of 6–8 weeks determined by clinical efficacy. • A 75% of reduction in hair density compared to base- line was observed in 61% of the treatment areas. • A photographic comparison was made using the Global Aesthetic Improvement Scale (GAIS) showing a mean of 3,6 (± 0.61) out of 4, being this an excellent improvement in every area. • The VAS scale was used to assess the pain in every session, and an average of 4.5 out of 10 was obtained, being this treatment very comfortable for all patients. There was no statistically significant difference between the “Blend” mode and the single-wavelength mode. • No side effects including paradoxical hypertrichosis were reported. • The advantage of using a high-power device, as in this study, is the uniform delivery of energy in short pulse du- rations. Further advantages the “Blend” mode is that they allow deep penetration into the dermis, with minimal risk of epidermal damage, this is especially important among patients with higher Fitzpatrick’s’ skin type.

Primelase - Clinical Book Clinical study of high-power diode laser in dynamic mode for fine hair removal: effect of pulse duration on efficacy and safety Aesthetic Medicine. July-September 2021: 20–28. Mariano Velez (1) Gregorio Viera (2) Gabriela Vergara (2). 1: Medical centre Ronefor, Barcelona, Spain - 2: Clinical and Scientific Department, Cocoon Medical, Barcelona, Spain. KE Y TAKE AWAY • 14 subjects with skin type II-III and brown-black hair were treated with diode laser using Primelase device. The parameters used for subjects with skin type II were: accumulated energy of 3.5 kJ, fluence of 8 J/cm2, and short pulse duration of 3 ms (high power: 4,800W) for the left side and long pulse duration of 14 ms (moderate power 1,000W) for the right side. The parameters used for subjects with skin type III were: accumulated energy of 3 kJ, fluence of 6 J/cm2, and short pulse duration of 3 ms (high power: 4,800W) for the left side and long pulse duration of 10 ms (moderate power: 1,000W) for the right side. Wavelength 810nm and same fluence on both sides. Of these subjects, 7 received treatment on the arms, 6 on the legs and 1 on the buttocks. • Greater overall hair reduction was observed using high power and shorter pulses (4800W and 3ms: 64%, SD 18%) compared to using moderate power and lon- ger pulses (1000W and 10-14ms: 55%, SD 18%), with a statistically significant improvement of 16% (p<0.024). Greater improvements were found in subjects with skin type II (27%, p<0.026) and brown hair (30%, p<0.0006), and also in areas with finer hair (56%, p<0.07). The appearance of oedema after treatment was greater on the side treated with 4800W (48%, p<0.03). • Subjects tended to feel mild pain with a mean score of 3.1 (SD 2.44) for 4,800W and a mean score of 2.9 (SD 1.86) for 1,000W (on a scale from 0 to 10), with the difference not being statistically significant (p<0.487). • Regarding complications or adverse effects (burns, blisters, crusting, ulcer infection, and possible hypo- or hyperpigmentation), they were not observed in any of the subjects. Safety and efficacy for hair removal in dark skin types III and IV with a high powered, combined wavelength (810,940 and 1060 nm) diode laser: A single-site pilot study Journal of Cosmetic Dermatology (J Cosmet Dermatol) 2022;00:1-7. Michael H. Gold, Julie Biron, April Wilson, Gregorio Viera Mármol, Reyna E Vargas Lamas, Marta Castillejos Pallas, Jose A Ferrandez Martinez. Tennessee Clinical Research Center, Nashville, Tennessee, USA - Clinical and Scientific Department at Cocoon Medical, Barcelona, Spain. KE Y TAKE AWAY • The study aimed to compare the efficacy, safety and comfort of a high-power device (4800W), applicator size 20x9 with two wavelengths: diode (810nm) and a combined (810 nm, 940 nm and 1060nm) in depilation treatments with dark phototypes.

Scientific Brief Safety and efficacy for hair removal in dark skin types III and IV with a high powered, combined wavelength (810,940 and 1060 nm) diode laser: A single-site pilot study Journal of Cosmetic Dermatology (J Cosmet Dermatol) 2022;00:1-7. Michael H. Gold, Julie Biron, April Wilson, Gregorio Viera Mármol, Reyna E Vargas Lamas, Marta Castillejos Pallas, Jose A Ferrandez Martinez. Tennessee Clinical Research Center, Nashville, Tennessee, USA - Clinical and Scientific Department at Cocoon Medical, Barcelona, Spain. KE Y TAKE AWAY • The study included 14 female patients with phototypes III and IV, comparing the two wavelengths in each armpit where 3 treatments were carried out with a period of 8 weeks between each session and the final evaluation 6 months after the last treatment. • The treatment parameters used in the two wavelengths were fluence of 13-21 J/cm2, pulse duration of 4-12 ms and frequency of 1 Hz. • In the treatments with the combined wavelength more fluence (40% (SE=0.04%)) was used than in the 810 nm wavelength, linking this increased of energy to a higher sensation of prickling and heat during the treatment. The combined applicator showed more than 1.8 points related to prickling and 1.9 points higher in heat sensation on the VAS scale compared with the 810 nm applicator (p<0.05). • All the patients reported erythema and edema immediately after treatment with both applicators. • No adverse effects were observed at either wavelength. • Six months after treatment an average of 47% (SE=5.1%) of hair was removed with the 810 nm applicator, while 53% (SE=5.3%) was removed with the combined applicator. Therefore, 12% more hair was removed using the combined applicator compared with the 810 nm applicator with a 70% of statistical confidence level. • Differences between skin types also was observed, for phototype III the hair reduction was 52% (SE=4.8%) with the 810 nm applicator and 54% (SE=6.7%) with the combined wavelength; meaning that 4% more hair was removed; in phototype IV hair reduction was 31% (SE=13.7%) with the 810 nm applicator and 51% (SE=4.9%) with the combined wavelength, thus 65% more hair was removed with the last one with an 85% confidence level. • The patient satisfaction very similar value was obtained fort both applicators. 50% of the participants were very satisfied with the results with the combined applicator, compared with 36% that were very satisfied with the 810 applicator.

Primelase - Clinical Book Efficacy of Permanent Laser Hair Removal with a High-Power Diode Laser and Air-Cooling of the Skin: A Small Sample Size Study International Research Journal of Pharmacy and Medical Sciences (IRJPMS) 2022; 5(2):26-31. Jose A. Ferrández-Martínez, Gregorio Viera-Mármol, Gabriela Vergara-Vallejo, Carmen Cano-Ochoa, Marta Castillejos-Pallàs, Jorge Villena-García, Reyna Vargas-Lamas. Clinical and Scientific Department, Cocoon Medical, Barcelona, Spain. KE Y TAKE AWAY • A comparative study is performed between air cooling and conventional contact cooling, using dynamic and static modes. A small sample size and a high-power diode laser were used. In addition, efficacy and safety were evaluated. • The comparative study included 16 subjects and 93 treatment areas with skin types ranging from II to V according to the Fitzpatrick classification. This comparison assessed the subjects’ pain or discomfort using the VAS scale (0-10). • To evaluate efficacy and safety, a study was performed on 4 subjects and 20 treatment areas. Efficacy was evaluated according to hair reduction 3 months after one treatment. • Parameters were set with a pulse duration of 3 ms and a fluence range of 3-8 J/cm2 at a frequency of 10 Hz in dynamic mode, and 6-100 ms and 9-21 J/cm2 at 1-3 Hz in static mode. • Statistically significant differences were not found in the comparison between air-cooling and contact-cooling. Both cooling systems produced a similar and moderate level of pain, with a pricking sensation being the prevailing type of pain due to selective heating of the hair. • In static mode, pain stayed mild-moderate on average with both air-cooling and contact- cooling (3.6, SD 2.46; and 4.24, SD 3.02, respectively), but in dynamic mode, pain was mild with air-cooling (2.23, SD 1.93) and mild with contact-cooling (3.43, SD 2.74). However, the difference was found to be statistically non-significant with both cooling systems (p > 0.05). • Regarding the efficacy and safety study, a 43.4% (SD 23%, p < 0.05) reduction was seen and no side effects were found to last more than 48 hours, with the results being classified as good to excellent for the treated subjects. • Regarding complications or adverse effects (burns, blisters, crusting, ulcer infection, and possible hypo- or hyperpigmentation), they were not observed in any of the subjects.

Technical sheet Plataform Primelase Type of device Diode LASER hair removal device Type of LASER Pulse Diode LASER emission Direct by quartz prism Technical characteristics 10000 w 300J Maximum electrical peak power Static 1-2-3 Hz Maximum energy Dinamic 5-10 Hz Operation Static Mode 3-400 ms Operation Dynamic Mode Yes Pulse duration Single phase, 100-240 V Programed parameters 50-60 Hz Power Supply 2800 w Network frequency 3300 w Nominal power 13A Maximum power Maximum Intensity Technical characteristics of diode laser 4800 w Maximum peak power Wavelength 755nm, 810nm, 940nm, 1060nm Spot size Fluence 20x9, 30x9, 30x17 Cooling According to treatment protocols Crystal freeze refrigeration contact cooling (+5°

Primelase - Clinical Book Regulation Primelase Directive mdd Class lb Class According to lec 60825-1 Class IV LASER Class According to lec 60601-1 Class I, type BF CE marking CE 0051 Guarantee 1 year Physical characteristics 1140x480x550 mm Dimensions Touchscreen 10,4” Screen 75 kg Weight 18-30 °C Work Range 2-50 °C <90% humidity (without condensation) Storage

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