CO2 Laser Coupler

K983965 is the FDA 510(k) clearance record for CO2 LASER COUPLER, a class II device, cleared for L.A.S.E.R., Inc. on 1998-12-22 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 11 510(k) clearances for L.A.S.E.R., Inc., from 1985-08-02 to 1998-12-22. As of 2026-09-10, FDA records show no recalls naming K983965.