Omnipulse Holmium Laser System, Model 1210; Omnipulse Max Holmium Laser System, Model 1210-Vhp and 1500-a

K002308 is the FDA 510(k) clearance record for OMNIPULSE HOLMIUM LASER SYSTEM, MODEL 1210; OMNIPULSE MAX HOLMIUM LASER SYSTEM, MODEL 1210-VHP AND 1500-A, a class II device, cleared for Trimedyne, Inc. on 2000-12-20 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 58 510(k) clearances for Trimedyne, Inc., from 1981-06-16 to 2005-12-21. As of 2026-09-10, FDA records show no recalls naming K002308.