
Leoni Fiber Optics, Inc.
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LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable is an FDA 510(k)-cleared medical device (K201171) manufactured by Leoni Fiber Optics, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 1, 2021. Regulation: 8.