FDA clears Cynosure to market picosecond laser for tattoo removal

The FDA has given 510(k) clearance to Cynosure to market its picosecond laser device for the removal of tattoos and benign pigmented lesions, the company announced.

The Westford, Mass.-based company expects to begin selling PicoSure in early 2013 to aesthetic dermatologists and plastic surgeons, according to a press release.

Twenty-two patients with multicolored and recalcitrant tattoos were treated with PicoSure for 2 weeks. Overall tattoo clearance exceeded 80%, with 94% clearance of blue and green ink on average, Cynosure reported.

“The picosecond laser’s shorter pulse duration erases tattoo pigment more efficiently, leading to a higher level of patient satisfaction and improved results compared with current [nanosecond] technology,” study researcher Roy Geronemus, MD, director of the Laser & Skin Surgery Center in New York, said in the release. “Our study shows that picosecond technology more effectively targets blue and green pigment, which is typically difficult to remove. In addition, PicoSure more rapidly lightens other colors, with improved recovery time due to less collateral injury to the surrounding tissue.”

“FDA clearance of PicoSure is a major milestone that caps nearly a decade of research and development at Cynosure to commercialize the world’s first safe and effective picosecond aesthetic laser specifically designed for the removal of tattoos and benign pigmented lesions,” Michael Davin, Cynosure president and CEO, said in the release.