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FDA 510(k)

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

K-Number: K201171 · 2021-04-02

ApplicantLeoni Fiber Optics, Inc.
Decision Date2021-04-02
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable is a medical device manufactured by Leoni Fiber Optics, Inc.. It received FDA 510(k) clearance on 2021-04-02 under approval number K201171. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

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. It is manufactured by Leoni Fiber Optics, Inc.. The 510(k) number is K201171.

When was LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable approved by the FDA?

LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable received FDA 510(k) clearance on 2021-04-02, under approval number K201171.

What company makes LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable?

LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable is manufactured by Leoni Fiber Optics, Inc..

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.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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