UltraLase Flexible CO2 Laser Waveguide

K211761 is the FDA 510(k) clearance record for UltraLase Flexible CO2 Laser Waveguide, a class II device, cleared for W & R Investments, LLC Dba Laser Engineering on 2021-07-30 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 W & R Investments, LLC Dba Laser Engineering. As of 2026-09-10, FDA records show no recalls naming K211761.