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Laseroptek Gets FDA’s 510(k) Clearance for its PicoLO Premium Dermatological Laser

December 21, 2021

South Korea’s Laseroptek has received the FDA’s 510(k) clearance for its PicoLO Premium picosecond pulse dermatological laser.

The clearance includes indications for skin rejuvenation, acne scars, benign pigmented lesion elimination and multicolor tattoo removal for a range of skin types. The laser features a range of newly developed handpieces.

The device will be available in the U.S. starting early in the new year, the Seoul-based company said. A previous version gained 510(k) clearance in early 2019.

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