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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Ophthalmic
510(k) Number K252979
Device Name Voyager DSLT (430840610)
Applicant
Belkin Vision, Ltd.
A Wholly Owned Subsidiary Of Alcon Laboratories, Inc.
13 Gan Rave Blvd.
Yavne,  IL 8122214
Applicant Contact Tamar Mor-Yosef Weizman
Correspondent
Regulatory Pathways Group, Inc.
440 N Barranca Ave. #2471
Covina,  CA  91723
Correspondent Contact Anne-Marie Ripley
Regulation Number886.4390
Classification Product Code
HQF  
Date Received09/17/2025
Decision Date 04/07/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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