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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lenses, Soft Contact, Daily Wear
510(k) Number K251683
Device Name Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Presbyopia (EDOF)
Applicant
Bruno Vision Care, LLC
2255 Glades Rd.
Suite 324a
Boca Raton,  FL  33431
Applicant Contact Eddie Catalfamo
Correspondent
Covington & Burling, Llp
850 10th St. NW
Washington,  DC  20001
Correspondent Contact Christina Kuhn
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received05/30/2025
Decision Date 12/23/2025
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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