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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 K230722
Device Name Eagle device
Applicant
Belkin Vision, Ltd.
13 Gan Rave Blvd.
Yavne,  IL 8122214
Applicant Contact Daria Lemann-Blumenthal
Correspondent
Regulatory Pathways Group, Inc.
440 N. Barranca Ave. #24 71
Covina,  CA  91723
Correspondent Contact Anne-Marie Ripley
Regulation Number886.4390
Classification Product Code
HQF  
Date Received03/16/2023
Decision Date 12/08/2023
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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