FDA clearance for PicoWay for all tattoo colours

Syneron Candela’s PicoWay laser has received FDA clearance for all tattoo colours.

The dual wavelength device, with 1064nm and 532nm wavelengths, utilises PicoWay Technology to generate picosecond pulses for the removal of tattoos. The FDA clearance is for red, yellow and orange for the 532nm wavelength and black, brown, green, blue and purple for the 1064nm wavelength.

In support of the FDA 510(K) clearance, the performance of the PicoWay system was evaluated in a prospective, US multi-centre study conducted by doctors Eric Bernstein, Arielle Kauvar and Tina Alster as the primary investigators. A large majority of subjects (86%) achieved at least 50% tattoo clearance after only three treatments based on blinded, independent review. Device treatment also presented a favourable safety profile with no device-related serious adverse events, and low levels of pain or discomfort throughout the study.

Dr Bernstein, who is president of Main Line Center for Laser Surgery, said, “PicoWay is an innovative and exciting breakthrough for tattoo removal. As a dual wavelength Nd:YAG laser, it delivers extremely high peak power, picosecond pulses enabling the treatment of all skin types. What this means is extremely impressive results, which translate into very happy patients. PicoWay is a game-changing laser for tattoo removal, and could not have come at a better time.”