Medilase System 2010L Laser Lithotriptor

K895837 is the FDA 510(k) clearance record for MEDILASE SYSTEM 2010L LASER LITHOTRIPTOR, a class II device, cleared for Medical Laser, Inc. on 1989-12-14 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 8 510(k) clearances for Medical Laser, Inc., from 1989-12-14 to 1991-11-01. As of 2026-09-10, FDA records show no recalls naming K895837.