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

Powered Laser Surgical Instrument

LEONI Fiber Optics, Inc.

The following data is part of a premarket notification filed by Leoni Fiber Optics, Inc. with the FDA for Leoni Laser Fibers: Barefiber Disposable, Barefiber Reusable And Endoprobe Disposable.

Pre-market Notification Details

Device IDK201171
510k NumberK201171
Device Name:LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable And Endoprobe Disposable
ClassificationPowered Laser Surgical Instrument
Applicant LEONI Fiber Optics, Inc. 209 Bulifants Blvd Williamsburg,  VA  23188
ContactMartin Trapp
CorrespondentPatsy J. Trisler
Qserve Group US, Inc. 7949 Beaumont Green East Drive Indianapolis,  IN  46250
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-01
Decision Date2021-04-02

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