Apex 800 Laser System, Model Apex 800

K020849 is the FDA 510(k) clearance record for APEX 800 LASER SYSTEM, MODEL APEX 800, a class II device, cleared for Iridex Corp on 2002-05-20 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 28 510(k) clearances for Iridex Corp, from 1998-09-08 to 2023-02-23. As of 2026-09-10, FDA records show no recalls naming K020849.