ACCENTO / HWA Dual/Single laser

K160227 is the FDA 510(k) clearance record for ACCENTO / HWA Dual/Single laser, a class II device, cleared for Bison Medical Co, Ltd. on 2016-04-22 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 3 510(k) clearances for Bison Medical Co, Ltd., from 2015-12-22 to 2016-11-02. As of 2026-09-10, FDA records show no recalls naming K160227.