CO2 Laser Therapy Systems

K162398 is the FDA 510(k) clearance record for CO2 Laser Therapy Systems, a class II device, cleared for Beijing Sincoheren Science and Technology Development Co. on 2017-07-06 under FDA product code ONG (Powered Laser Surgical Instrument With MicrobeamFractional Output). FDA's definition for product code ONG reads: "A LASER (Light Amplification by Stimulated Emission of Radiation) based device having coherence, collimated and typically monochromatic radiation. The laser output is in form of tiny beams in micro range. Typically, indicated to be used in...". FDA records list 2 510(k) clearances for Beijing Sincoheren Science and Technology Development Co., from 2017-02-02 to 2017-07-06. As of 2026-09-10, FDA records show no recalls naming K162398.