NS3000 Holmium Laser System

K142286 is the FDA 510(k) clearance record for NS3000 Holmium Laser System, a class II device, cleared for New Star Lasers, Inc. on 2014-10-31 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 29 510(k) clearances for New Star Lasers, Inc., from 1995-03-09 to 2014-10-31. As of 2026-09-10, FDA records show one recall naming K142286.