Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories

K170121 is the FDA 510(k) clearance record for Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories, a class II device, cleared for Lumenis, Ltd. on 2017-05-22 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 83 510(k) clearances for Lumenis, Ltd., from 1979-11-16 to 2026-06-02. As of 2026-09-10, FDA records show one recall naming K170121.