Fencer 308 Excimer Laser System

K080975 is the FDA 510(k) clearance record for FENCER 308 EXCIMER LASER SYSTEM, a class II device, cleared for Kera Harvest/Laser Max Medical Technologies Corp on 2008-07-15 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 one 510(k) clearance for Kera Harvest/Laser Max Medical Technologies Corp. As of 2026-09-10, FDA records show no recalls naming K080975.