Speed 808 Diode Laser System

K132989 is the FDA 510(k) clearance record for SPEED 808 DIODE LASER SYSTEM, a class II device, cleared for Beijing Toplaser Technology Co., Ltd. on 2014-01-23 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 Beijing Toplaser Technology Co., Ltd., from 2014-01-23 to 2014-04-18. As of 2026-09-10, FDA records show no recalls naming K132989.