HandPICO

K220041 is the FDA 510(k) clearance record for HandPICO, a class II device, cleared for Vydence Medical Industria E Comercio Ltda on 2022-05-05 under FDA product code GEX (Powered Laser Surgical Instrument). FDA's definition for product code GEX reads: "A laser (light amplification by stimulated emission of radiation) based device having coherence, collimated and typically monochromatic radiation. Typically indicated to to cut, destroy, remove or coagulate tissue, generally soft tissue...". FDA records list 4 510(k) clearances for Vydence Medical Industria E Comercio Ltda, from 2018-04-20 to 2022-05-05. As of 2026-09-10, FDA records show no recalls naming K220041.