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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 K210975
Device Name Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia
Applicant
Bausch & Lomb Incorporated
1400 North Goodman Street
Rochester,  NY  14609
Applicant Contact Barbara Klube-Falso
Correspondent
Bausch & Lomb Incorporated
1400 North Goodman Street
Rochester,  NY  14609
Correspondent Contact Barbara Klube-Falso
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received04/01/2021
Decision Date 05/24/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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