Cynosure Announces FDA Clearance of New 532 nm Laser Delivery System for PicoSure®
New System Slated for Introduction at American Academy of Dermatology 2015 Annual Meeting
WESTFORD, Mass., -- Cynosure, Inc. (NASDAQ: CYNO) today announced FDA 510(k) clearance of its new 532 nm Laser Delivery System for PicoSure®, creating a powerful, dual-wavelength laser system for removing tattoos of all colors in fewer treatments. PicoSure, the world's first picosecond aesthetic laser, is widely recognized for its technology leadership, unmatched clinical versatility and proven performance.
"The new 532 nm Laser Delivery System further builds on the clinical and commercial success of the 755 nm PicoSure for the removal of tattoos and benign pigmented lesions as well as the treatment of acne scars and wrinkles," said Cynosure Chairman and Chief Executive Officer Michael Davin. "We are pleased to offer this system as an upgrade to our current PicoSure customer base."
"The integration of the 532 nm wavelength into the PicoSure platform allows for more effective removal of red, orange and yellow tattoo ink, which can now be cleared in fewer treatments," said Roy G. Geronemus, M.D., Director of the Laser & Skin Surgery Center of New York. "Based on my picosecond wavelength clinical experience, I believe that the combination of PicoSure's 755 nm and 532 nm wavelengths provides unmatched tattoo clearance across the full color spectrum."
Cynosure expects to introduce the 532 nm Laser Delivery System for PicoSure at the American Academy of Dermatology's 2015 Annual Meeting March 20-24 in San Francisco. Initial shipments are expected to begin by the end of the second quarter of 2015.
About Cynosure, Inc.
Cynosure designs, manufactures and markets medical devices for aesthetic procedures and precision surgical applications worldwide. The Company's products enable plastic surgeons, dermatologists and other medical practitioners to perform non-invasive and minimally invasive procedures to remove hair, treat vascular and benign pigmented lesions, remove multi-colored tattoos, revitalize the skin, liquefy and remove unwanted fat through laser lipolysis, reduce cellulite, clear nails infected by toe fungus, ablate sweat glands and improve vaginal health. Cynosure also markets radiofrequency energy sourced medical devices for precision surgical applications such as facial plastic and general surgery, gynecology, ear, nose, and throat procedures, ophthalmology, oral and maxillofacial surgery, podiatry and proctology. Cynosure's product portfolio is composed of a broad range of energy sources including Alexandrite, diode, Nd: YAG, picosecond, pulse dye, Q-switched lasers, intense pulsed light and radiofrequency technology. Cynosure sells its products globally under the Cynosure, Palomar, ConBio and Ellman brand names through a direct sales force in the United States, Canada, Mexico, France, Germany, Spain, the United Kingdom, Australia, China, Japan and Korea, and through international distributors in approximately 120 other countries. For corporate or product information, visit Cynosure's website at www.cynosure.com.
