Photex Diode Laser Series, Models 980, 810 and 940

K060304 is the FDA 510(k) clearance record for PHOTEX DIODE LASER SERIES, MODELS 980, 810 AND 940, a class II device, cleared for Biotex, Inc. on 2006-03-21 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 10 510(k) clearances for Biotex, Inc., from 2006-03-01 to 2024-05-21. As of 2026-09-10, FDA records show no recalls naming K060304.