Indigo Optima Laser System, Optima Diffuser-Tip Fiberoptic-Bph, Optima Bare-Tip Fiberoptic,optima Laser Cart with Prints

K023182 is the FDA 510(k) clearance record for INDIGO OPTIMA LASER SYSTEM, OPTIMA DIFFUSER-TIP FIBEROPTIC-BPH, OPTIMA BARE-TIP FIBEROPTIC,OPTIMA LASER CART WITH PRINTS, a class II device, cleared for Ethicon Endo-Surgery, Inc. on 2002-10-24 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 185 510(k) clearances for Ethicon Endo-Surgery, Inc., from 1992-09-09 to 2026-05-11. As of 2026-09-10, FDA records show no recalls naming K023182.