Laser Endoscopic Decompression Kit, Model 1100, and Percutaneous Discectomy Kit, Model 1120

K040424 is the FDA 510(k) clearance record for LASER ENDOSCOPIC DECOMPRESSION KIT, MODEL 1100, AND PERCUTANEOUS DISCECTOMY KIT, MODEL 1120, a class II device, cleared for Clarus Medical, LLC on 2004-05-11 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 10 510(k) clearances for Clarus Medical, LLC, from 2001-12-13 to 2026-05-26. As of 2026-09-10, FDA records show one recall naming K040424.