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

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00851925007625 K201171 000
00851925007526 K201171 000
00851925007533 K201171 000
00851925007540 K201171 000
00851925007557 K201171 000
00851925007564 K201171 000
00851925007571 K201171 000
00851925007588 K201171 000
00851925007595 K201171 000
00851925007601 K201171 000
00851925007618 K201171 000
00851925007519 K201171 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.