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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name photocoagulator and accessories
510(k) Number K182646
Device Name Vitreq disposable laser probes, light fibers and Chandelier
Vitreq B.V.
Segglant-Noord 2
Vierpolders,  NL 3237MG
Applicant Contact JanKees Wouts
Beaver-Visitec International, Inc.
500 Totten Pond Rd - 10 CityPoint
Waltham,  MA  02451
Correspondent Contact Genci Omari
Regulation Number886.4690
Classification Product Code
Subsequent Product Codes
Date Received09/24/2018
Decision Date 05/01/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No