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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K201171
Device Name LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable
Applicant
Leoni Fiber Optics, Inc.
209 Bulifants Blvd.
Williamsburg,  VA  23188
Applicant Contact Martin Trapp
Correspondent
Qserve Group, Us, Inc.
7949 Beaumont Green E. Dr.
Indianapolis,  IN  46250
Correspondent Contact Patsy J. Trisler
Regulation Number878.4810
Classification Product Code
GEX  
Date Received05/01/2020
Decision Date 04/02/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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