The PicoWay® picosecond laser from Syneron Candela has received U.S. Food and Drug Administration (FDA) clearance for a new 785nm wavelength with ultra-short pulse. This is the third FDA cleared wavelength for PicoWay. The new ultra-short 785nm wavelength is the first of its kind in the aesthetic market. It utilizes a titanium sapphire laser to remove blue and green tattoos.
FDA approval for a new 785 nm wavelength was based on a study covering 22 tattoos, of which 18 contained blue and green ink. Evaluation of tattoo removal by different physicians showed that 83% of the processed blue-green tattoos had from “good” to “complete” removal after two treatments with PicoWay laser using 785 nm wavelength . During the treatment no complications developed and the procedure itself was very comfortable for most of the patients.
Eric F. Bernstein, MD, MSE, director of the Laser Surgery Center in Philadelphia, Pennsylvania, and the chairman of the Medical Advisory Board of Candela Laser Corporation, was the chief clinical research leader in the FDA resolution of 785 nm for the PicoWay laser.
Dr. Bernstein noted: “This is the world’s first laser with a wavelength of 785 nm with a picosecond pulse. This new application 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’m very impressed with Jay Bhawalkar and the team of engineers from Syneron Candela, who developed the PicoWay laser. The new 785 nm wavelength further extends the already powerful capabilities of the PicoWay platform to remove multi-colored tattoos. I am very pleased to offer this new wavelength to my patients and am honored to conduct clinical trials leading to FDA approval for the PicoWay laser and this new wavelength. ”
The innovative laser platform PicoWay provides ultra-short energy pulses (for example, 300 picoseconds at 785 nm), making the treatment shorter and more comfortable for patients, offering the industry’s shortest pulses and the highest peak power. Adding a third wavelength allows you to completely eliminate and process all the colors of tattoos and pigment lesions. The PicoWay picosecond laser was previously approved by the FDA for the removal of tattoos in November 2014 and the treatment of pigmented lesions in April 2015.
Amit Meridor, Chief Executive Officer of Syneron Candela, said: “We are pleased to receive FDA approval for a new wavelength of 785 nm for PicoWay, which increases its ability to remove blue and green tattoo inks. With the addition of this third wavelength, the PicoWay laser can now perform procedures with the ability to comprehensively remove and treat all the colors of tattoos and skin pigmentation. We look forward to providing this opportunity to new and existing PicoWay customers in the US, starting in the fourth quarter. “