FDA Clears New 532 nm Laser Delivery System for PicoSure from Cynosure

February 23, 2015

Cynosure, Inc. received 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 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, MD, 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.

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