Azuryt Model Ctl 1401, CO2 Surgical Laser System

K062248 is the FDA 510(k) clearance record for AZURYT MODEL CTL 1401, CO2 SURGICAL LASER SYSTEM, a class II device, cleared for North American Clinical Lasers, Ltd. on 2006-08-17 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 one 510(k) clearance for North American Clinical Lasers, Ltd. As of 2026-09-10, FDA records show no recalls naming K062248.