Dec. 4, 2012
/PRNewswire/ -- Cynosure, Inc. (Nasdaq: CYNO) a leader in laser- and light-based treatments for minimally invasive and non-invasive aesthetic applications, today announced that it has received FDA 510(k) clearance to market the PicoSure™ laser workstation for the removal of tattoos and benign pigmented lesions. The Company expects to sell PicoSure initially through its U.S. direct sales force to aesthetic dermatologists and plastic surgeons beginning in early 2013.
"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," said President and CEO
. "PicoSure accomplishes this by delivering short-pulse bursts of energy to the skin in
of a second. With data indicating that an estimated 20 percent of the 45 million Americans with at least one tattoo want to have it removed, the FDA clearance of PicoSure creates a first-mover advantage for Cynosure to treat a large and vastly underserved market."
, M.D., Director of the Laser & Skin Surgery Center of
, performed a study in which 22 subjects with multicolored and recalcitrant tattoos were treated with PicoSure over a two-week period. The results demonstrated greater than 80% overall tattoo clearance. On average, 94% clearance was achieved for blue and green ink.
"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," Dr. Geronemus said. "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."