Syneron Medical said today it won FDA 510(k) clearance for a new ultra-short 785nm wavelength laser for its PicoWay picosecond laser device.
The PicoWay system is an aesthetic laser system designed for removing tattoos of all colors and types and treating pigmented lesions. The system won FDA clearance for the removal of tattoos in November, 2014 and for the treatment of pigmented lesions in April, 2015.
The company touts the device as the 1st of its kind to win such clearance for the aesthetic market. The new ultra-short 785nm wavelength laser uses a titanium sapphire laser for the removal of blue and green inks.
“This is the 1st, 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. I am extremely impressed with Jay Bhawalkar and his engineering team at Candela, who developed the PicoWay. 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, and honored to have lead the clinical trial leading to FDA clearance of the PicoWay and this new wavelength,” principal investigator Dr. Eric Bernstein of Philadelphia’s Main Line Center for Laser Surgery said in a press release.
Syneron said it plans to make the device available in the U.S. in the 4th quarter of this year to new and existing PicoWay customers.
“We are pleased to receive FDA clearance for the new 785nm wavelength for PicoWay, which enhances its ability to remove blue and green tattoo ink. With the addition of this third wavelength, PicoWay can now provide practices with the ability to provide comprehensive removal and treatment of all colors of tattoos and skin pigmentation. We look forward to making this feature available to new and existing PicoWay customers in the U.S. beginning in the fourth quarter,” CEO Amit Meridor said in prepared remarks.