Cynosure Receives FDA Clearance to Market PicoSure Energy Delivery System for Tattoos and Pigmented Lesions


The FDA granted clearance to Cynosure to market a new Laser Delivery System for PicoSure. Together with the FDA cleared 532nm and 755nm wavelengths, Cynosure's new 1064nm Laser Delivery System improves the multi-wavelength laser technology for removing the full color spectrum of tattoo inks in fewer treatments.

The new 1064nm wavelength is designed for removal of black and other dark tattoo inks. Engineered to complement the highly versatile 755nm wavelength and the company's proprietary FOCUS Lens Array, the 1064nm and 532nm laser delivery systems enhance PicoSure's ability to remove tattoos and treat a range of dermatologic conditions including wrinkles, acne scars and pigmented lesions.

"PicoSure is widely recognized by aesthetic practitioners for its unsurpassed clinical efficacy and proven performance," said Cynosure Chief Executive Officer Michael Davin. "Consumers simply know it works. With the FDA clearance of the 1064nm Laser Delivery System we believe our picosecond technology has the broadest range of clearances on the market. The new 1064nm wavelength builds on our aesthetic industry leadership and expands PicoSure's versatility for tattoos, pigmentation and skin revitalization."

The 1064nm wavelength will be offered as an upgrade to existing PicoSure customers. Initial shipments of the new Laser Delivery System are expected to begin in the second half of 2016.

The clinical experience with PicoSure was the subject of 11 oral abstracts and three ePosters during the recent American Society for Laser Medicine & Surgery Annual Conference in Boston. In addition to tattoo removal and skin revitalization, researchers reported on studies evaluating PicoSure as a treatment for melasma, a hyperpigmentation of the skin more common in women.

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