LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable

K201171 is the FDA 510(k) clearance record for LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable, a class II device, cleared for Leoni Fiber Optics, Inc. on 2021-04-02 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 Leoni Fiber Optics, Inc. As of 2026-09-10, FDA records show no recalls naming K201171.