LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable
K-Number: K201171 · 2021-04-02
Device Summary
Frequently Asked Questions
What is the LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable?
LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable is a medical device that received FDA 510(k) clearance on 2021-04-02. The listed applicant is Leoni Fiber Optics, Inc.. The 510(k) number is K201171.
When did LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable receive FDA 510(k) clearance?
LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable received FDA 510(k) clearance on 2021-04-02, under 510(k) number K201171.
Who is the listed applicant for LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable?
The FDA 510(k) record lists Leoni Fiber Optics, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable?
The FDA product code for LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable is GEX. This falls under the Gastroenterology category.
Related Devices (Code: GEX)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
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