PicoWay Receives FDA Approval for 785nm Wavelength

Candela’s PicoWay® picosecond laser has received FDA approval for its new ultrashort 785 nm wavelength, the third FDA-cleared wavelength for PicoWay. The new 785 nm wavelength is the first of its kind in the aesthetic market, utilizing a titanium-sapphire laser for the removal of blue and green tattoo ink.

The FDA approval of the new ultrashort 785 nm wavelength was supported by 15 patient studies covering 22 tattoos, 18 of which contained blue and green ink. Tattoo lightening evaluations by independent, board-certified physicians showed that 83% of treated blue-green tattoos had “good” to “complete” removal after two treatments with the PicoWay 785 nm laser. There were no complications during treatment, and the PicoWay picosecond laser procedure was generally completely comfortable for most patients.

Eric F. Bernstein, MD, MSE, Director of the Laser Surgery Center in suburban Philadelphia, Pennsylvania, and Chairman of the Medical Advisory Board of Candela Laser Corporation, was the Principal Investigator of the clinical trial that led to FDA approval of the 785 nm wavelength for the PicoWay laser.

Dr. Bernstein noted, “This is the world’s first 785 nm laser with a picosecond pulse. This new addition to the PicoWay laser provides optimal treatment for blue and green tattoos and is a welcome addition to the 532 and 1064 nm wavelengths already available in the PicoWay picosecond laser. I am very impressed with Jay Bhawalkar and the engineering team at Candela, who developed the PicoWay laser. The new 785 nm wavelength further expands the already powerful capabilities of the PicoWay platform for multicolor tattoo removal. I am thrilled to offer this new wavelength to my patients and honored to lead the clinical trials leading to FDA approval for the PicoWay laser and this new wavelength.”

The innovative PicoWay laser platform delivers ultra-short pulses of energy (e.g., 300 picoseconds at 785 nm), making treatments shorter and more comfortable for patients, offering the shortest pulses in the industry and the highest peak power. The addition of a third wavelength completes the PicoWay laser platform, enabling complete removal and treatment of all colors of tattoos and pigmented lesions. The PicoWay picosecond laser previously received FDA approval for tattoo removal in November 2014 and for the treatment of pigmented lesions in April 2015.

Amit Meridor, CEO of Syneron Candela, said: “We are pleased to receive FDA approval for the new 785 nm wavelength for PicoWay, which increases its ability to remove blue and green tattoo ink. With the addition of this third wavelength, the PicoWay laser can now perform treatments with comprehensive removal and treatment capabilities for all tattoo colors and skin pigmentation. We look forward to bringing this capability to new and existing PicoWay customers in the US beginning in the fourth quarter.”