Melanocytic Nevus Syndrome, Congenital

MARLBOROUGH, Mass., March 15, 2023 /PRNewswire/ -- Candela Corporation (Candela), a leading global medical aesthetic device company headquartered in Marlborough, MA, today announced that the PicoWay® laser system has received FDA clearance and Health Canada licensing for expanded indications, including the challenging condition of melasma. In addition to its earlier indications for wrinkles, benign pigmented lesions, tattoo removal, and acne scars, the new clearance and license expand the platform's capabilities to include treatment of melasma, lentigines, café au lait macules (CALMs), and Nevus of Ota.1-2 The award-winning PicoWay laser platform is a leading picosecond system globally. It has the broadest range of FDA cleared indications of any picosecond laser.* The platform has four true picosecond wavelengths (532, 730, 785 and 1064 nm) and offers treatment versatility with multiple available applicators and beam delivery technologies (full beam, microbeam and "Fusion" beam).1,3 The distinctive ultra-short pulse of the PicoWay laser delivers photoacoustic, rather than photothermal energy, reaching targets like pigment under the top layer of skin, while minimizing the risk of overheating the outer skin layer. The consistent photoacoustic treatment modality of the device allows for minimal post-treatment downtime, making PicoWay system the ideal laser for the growing skin rejuvenation** and tattoo removal markets, and for those with pigmentation disorders. For darker skin types who often experience pigmentary conditions, PicoWay is the laser of choice. Slower, longer-pulsed lasers, or those that do not consistently deliver advertised energy levels or pulse durations, place this demographic at higher risk of hypo- or hyperpigmentation that can result from excess heat delivery.3 Melasma is a skin condition that causes patches of spots, usually on the face, which are darker than one's natural skin tone.4 The condition is common in darker skin types and especially prevalent in pregnant women due to hormonal changes - between 15% to 50% of pregnant women*** will get melasma, leading the condition often to be referred to as the "mask of pregnancy".5,6 A complicated skin disorder, often attempted to be managed with topicals and frequently relapsing and remitting for long periods, melasma can be notoriously challenging to treat.7 "Addressing melasma with the PicoWay laser gives patients an important treatment modality to manage this difficult and often psychologically upsetting condition. Patients now have a treatment that specifically targets their pigmentary changes and can be used alongside other treatments like topicals to better manage this complex skin disorder," states double board-certified Dermatologist Douglas Wu, MD, PhD of Cosmetic Laser Dermatology in San Diego and Rejuvenation Dermatology in Canada. "The new PicoWay laser clearances add to the already impressive capabilities of this platform. Candela is committed to investing in clinical research and expanding our products' range of cleared clinical indications. The PicoWay system's newest clearances allow our customers to continue benefiting from their partnership with Candela and offer their patients another clinically proven option for the treatment of melasma," said Geoff Crouse, CEO of Candela. * As of January October 2022. **As defined by reduction in pigmentation, wrinkles and/or acne scarring. ***The PicoWay laser is contraindicated for use during pregnancy. References PicoWay Laser 510(k) clearance (K220853), October 2022. PicoWay Laser Health Canada Licence (94931), Amended 2023/2/13. Data on file, Candela, 2023. (Accessed February 13, 2023). Visit Candela or PicoWay Laser for further information. © 2023 Candela Corporation. This material contains registered and unregistered trademarks, trade-names, service marks, and brand names of Candela Corporation and its affiliates. All other trademarks are the property of their respective owners. All rights reserved. Media Contact: Laurel Sanderson [email protected] SOURCE Candela

AVAVA is a disruptive medical aesthetics technology platform company providing breakthrough treatments for all skin tones FDA Center for Devices and Radiological Health. (Credit: The U.S. Food and Drug Administration/Wikipedia) AVAVA Inc. (“AVAVA” or the “Company”), a disruptive medical aesthetics technology platform company providing breakthrough treatments for all skin tones, today announced that its AVAVA pigment disorder product has received FDA 510(k) clearance to treat benign pigmented lesions of the skin, including hyperpigmentation. This clearance marks AVAVA’s second received from the FDA for its new class of focused intradermal laser products powered by Focal Point Technology™ to deliver energy at any depth with pinpoint accuracy for ideal patient outcomes. Dr. Irina Erenburg, CEO of AVAVA, said, “We are thrilled to announce our FDA clearance, a key milestone achievement for AVAVA, as we move to address the unmet needs of over 4 million women with pigmentary disorders, a $1 billion annual procedure market.” Dr. Erenburg added, “In pioneering our technology, we harnessed over 30 years of clinical experience and developed an AI enabled, precise three-dimensional laser treatment that results in the optical breakdown of melanin (pigment), whether near the surface or deep under the skin. This achieves an optimal patient and provider experience without pain, downtime, or side effects. We look forward to continuing to build a body of clinical evidence supporting our indication and to finally offering to the clinical community a best-in-class solution for pigmentary disorders, a top 5 concern for skin of color patients in the US.” “In today’s treatment market, where the lack of effective solutions for pigment disorders is well understood, we warmly welcome and are excited to be able provide the AVAVA therapy to our patients. We believe that with AVAVA, there is finally hope for patients with hyperpigmentation, dark spots after acne, and other pigmentary disorders, who have given up or chosen to not seek treatment,” said Dr. Roy G. Geronemus, Director of the Laser & Skin Surgery Center of New York and CEO of Navaderm Partners. The AVAVA Focal Point Technology™ is complemented by a high-resolution interactive imaging system, which provides inter- and intra-treatment intelligence to map and guide real-time therapy with actionable data, to unlock safe and effective treatments for all skin tones. Source: Company Press Release

The Agreement covers the sales & marketing of LASEROPTEK's expanding line of FDA cleared aesthetic laser systems to the U.S. market. SEOUL, Republic of Korea, July 8, 2022 /PRNewswire/ -- LASEROPTEK Co., Ltd., a developer and manufacturer of world-class lasers for medical aesthetic and dermatology indications, is pleased to announce it signed a nationwide, multi-year, exclusive distribution agreement with Monarch Lasers. The agreement covers sales, marketing and clinical education for LASEROPTEK's lineup of U.S. FDA cleared laser systems designed for medical aesthetic indications in the U.S. market. Continue Reading LASEROPTEK's PicoLO Premium Advanced Picosecond Nd:YAG Laser featuring industry leading stability and novel selectable depth control 1064nm LIOB generation via the included Dia FX 1064 handpiece. Delivers fast & efficacious treatments across a wide range of medical aesthetic indications such as Skin Rejuvenation, Benign Pigmented Lesions, Acne Scars, Large Pores, Tattoo removal, and many others. Available in the U.S. exclusively through Monarch Lasers. Helios III, LASEROPTEK's gold standard nanosecond Nd:YAG Q-Switched Laser enables fast, economical and efficacious treatments across a wide range of medical aesthetic indications. Helios III features proven stability from a global installation base. Now exclusively available in the U.S. through Monarch Lasers. "The U.S. represents a significant business opportunity for LASEROPTEK and the partnership with Monarch Lasers highlights our commitment to the U.S. market to develop and commercialize novel devices," this according to CJ Lee, CEO of LASEROPTEK. "I am energized to work with Kevin Meyers and his team of medical aesthetic sales and clinical education professionals at Monarch Lasers," Christopher Dalton, Vice President of LASEROPTEK stated. "Monarch's deep experience and solid reputation in the U.S. is evidenced by a combination of sales growth and long-term relationships fostered with their clinician customers. Our partnership is designed to maximize the synergy between LASEROPTEK and Monarch, making LASEROPTEK's world-class, value-delivering medical aesthetic lasers easily accessible to U.S. clinicians," added Dalton. Commenting on the agreement, Kevin Meyers, Managing Partner of Monarch said, "Monarch is excited to partner with LASEROPTEK to offer the BEST-IN-CLASS line of pico and nano second lasers to the US medical aesthetic market. We are impressed by LASEROPTEK's ability to design and manufacture lasers from the ground up ensuring industry leading stability, efficacy, and performance." Touching on Monarch's decision-making process, Kevin adds, "I have been in the industry for many years, so when we evaluate equipment to decide whether to get involved, we look at four main criteria; 1. Efficacy: Does it perform up to expectations? 2. Is it safe and easy to delegate to staff members? 3. Is the equipment durable and reliable, and 4. Does the return on investment make sense to our customers? If we get a positive answer to those questions, we then look at the people we are working with and their commitment to our customers' success. When it came to working with LASEROPTEK and their lasers, all the answers to our questions are a resounding YES." To learn more about LASEROPTEK's world-class lineup of lasers for medical aesthetics, please contact Monarch Lasers at +1(866) 599-5570 or visit . For more information on LASEROPTEK and our complete line of lasers for both medical and aesthetic indications, please visit . About LASEROPTEK Co., Ltd. LASEROPTEK is a global technology-driven medical device company in the aesthetic and medical laser space. Founded in 2000 and with in-house R&D capabilities, LASEROPTEK introduces safe, stable and high-quality laser systems merging advanced laser technology with clinical efficacy. About Monarch Lasers Monarch Lasers was founded to provide medical and health care professionals the latest in laser and aesthetic technology. The Monarch Advantage: Service, Support, Value. Since our inception, we've been focused on a single goal: "Offer the very best combination of equipment and services to our customers. Whether you are an experienced Aesthetic center or are considering incorporating these highly profitable procedures into your practice, Monarch Lasers can help. On the web at Media Contacts: Helena Lee [email protected] +82 31-8023-5150 Christopher Dalton [email protected] +1(619) 997-7905 SOURCE LASEROPTEK Co. Ltd.