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

Leoni Fiber Optics, Inc.

Country / region:United States (US)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

2

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K201171
Device name
LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable
Country / region
United States(US)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2020-05-01
Decision date
2021-04-02
Submission type
Traditional
Technology type
Laser fiber / delivery(AI inferred)
Clinical applications
Surgical cuttingVascular treatmentOtherSkin resurfacing
Primary application
Surgical cutting
Classification source
AI classified

Indications for Use

LEONI TM Laser Fibers (BareFiber Disposable, BareFiber Reusable, and Endoprobe Disposable) are intended for use with any cleared surgical laser with an SMA 905 connector, SMA 906 connector, or manufacturer specific connectors and adaptors. The Laser Fiber is indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 500nm - 2200nm have received regulatory clearance. The disposable contact and the reusable non-contact Fiber Optic Delivery System is intended to vaporize, coagulate and incise and excise tissue and are cleared for any indication for which compatible Nd: YAG, Ho YAG, KTP and Diode Laser Systems have been cleared by the FDA. The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedures for cutting, coagulating, or vaporizing in any soft tissue application for which compatible Nd: YAG, Ho: YAG, KTP and Diode lasers have been cleared.

Intended Use

LEONI TM Laser Fibers (BareFiber Disposable, BareFiber Reusable, and Endoprobe Disposable) are intended for use with any cleared surgical laser with an SMA 905 connector, SMA 906 connector, or manufacturer specific connectors and adaptors. The Laser Fiber is indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 500nm - 2200nm have received regulatory clearance. The disposable contact and the reusable non-contact Fiber Optic Delivery System is intended to vaporize, coagulate and incise and excise tissue and are cleared for any indication for which compatible Nd: YAG, Ho YAG, KTP and Diode Laser Systems have been cleared by the FDA. The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedures for cutting, coagulating, or vaporizing in any soft tissue application for which compatible Nd: YAG, Ho: YAG, KTP and Diode lasers have been cleared.

Device Description

The fiber optic delivery systems are accessories designed to deliver optical energy to soft or fibrous tissue in general surgical applications, in combination with any SMA-compatible laser system also indicated for the same applications. They are composed of silicon, polyimide, acrylate, and polyamide. The device systems are available in multiple sizes and with multiple tip shapes and handpiece configurations. The fiber optics are available in reusable, and single use disposable devices that are prepackaged sterile. The reusable fiber optic systems may be reused only after the optical fiber tip is cleaned according to the Instructions for Use.

Summary parsed at:2026-06-01 05:41:16 UTC

Predicate devices

2

K201171 references 2 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K201171 as a predicate