FDA Grants 510(k) Clearance to Laseroptek's PicoLO

Laseroptek’s PicoLO picosecond Nd:YAG laser is now U.S. Food and Drug Administration-cleared for marketing in dermatology and general and plastic surgery.

According to the company, PicoLO generates high peak power and consistent picosecond pulse duration producing strong photomechanical forces within the skin to breakdown and fragment pigments such as those found in tattoos. In addition, PicoLO incorporates Laseroptek 's patented Diffractive Optical Element (DOE) fractional technology which creates Laser-induced Optical Breakdown (LIOB) in the dermis even at low power.

"Exceptionally stable energy output and picosecond pulse duration are key technological developments integrated into PicoLO further distancing it from the competition. High stability in both laser output and pulse duration is central to delivering consistently efficacious treatment outcomes while simultaneously minimizing patient discomfort," says C.J. Lee, CEO of Laseroptek, in a news release.

The company’s  LOTUS III^TM multi-pulsed Er:YAG laser received 510(k) clearance at the end of 2018. PicoLO and LOTUS III will make their North American debuts at the 2019 American Academy of Dermatology Conference to be held March 1^st thru 5^th in Washington, D.C. and at the 2019 American Society for Laser Medicine & Surgery meeting held March 27^th thru 31^st in Denver, Colo.