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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 K234127
Device Name Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact Lens with UV Blocker
Applicant
CooperVision, Inc.
6101 Bollinger Canyon Road, Suite 500
San Ramon,  CA  94583
Applicant Contact Sahana Rajashekar
Correspondent
CooperVision, Inc.
6101 Bollinger Canyon Road, Suite 500
San Ramon,  CA  94583
Correspondent Contact Sahana Rajashekar
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received12/28/2023
Decision Date 01/25/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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