Syneron Candela's PicoWay Picosecond Laser Receives U.S. FDA Clearance for Ultra-Short 785nm Wavelength


And then there were three.

The U.S. Food and Drug Administration (FDA) has cleared Syneron Medical Ltd.’s PicoWay® picosecond laser for a new ultra-short 785nm wavelength.

The addition of the new wavelength expands the capabilities of the PicoWay picosecond laser, making it possible to remove all tattoo ink colors including blue and green.

It will be available in the fourth quarter of 2016, the company states.

The FDA clearance of the new third wavelength was supported by a 15 patient study, covering 22 tattoos, of which 18 contained blue and green inks. Blinded evaluation of tattoo clearance, by independent board-certified physicians, showed that 83 percent of the treated blue/green tattoos had "good" to "complete" treatment response after two PicoWay treatments with the 785nm wavelength. Moreover, investigator assessments of tattoo clearance showed similar results to blinded evaluation findings.

There were no treatment complications, and PicoWay treatments were generally associated with no discomfort to mild discomfort for the majority of treatments.

"This is the first, ever, 785nm wavelength picosecond-domain laser in the world. This novel addition to the PicoWay enables optimal treatment for blue and green tattoos, and is a welcome addition to the 532 and 1,064nm wavelengths already available with the PicoWay,” says Eric F. Bernstein, MD, MSE, Director of the Main Line Center for Laser Surgery in suburban Philadelphia, PA, and Chairman of the Candela Laser Corporation Medical Advisory Board, in a news release. Dr. Bernstein was the principal investigator for the clinical study resulting in FDA clearance of the new 785nm wavelength for PicoWay laser. “The new 785nm wavelength further enhances the already strong capabilities of the PicoWay platform for tattoo removal, adding to its ability to rapidly and safely clear multicolored tattoos. I am thrilled to offer this new wavelength to my patients."

 The PicoWay picosecond laser previously received FDA clearance for the removal of tattoos in November 2014 and the treatment of pigmented lesions in April 2015.


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