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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 K262941
Device Name Bausch + Lomb Multifocal for Astigmatism (kalifilcon A) One-Day Soft (hydrophilic) Contact Lens
Applicant
Bausch + Lomb, Inc.
1400 N Goodman St.
Rochester,  NY  14609
Applicant Contact Kaelan Sarin
Correspondent
Bausch + Lomb, Inc.
1400 N Goodman St.
Rochester,  NY  14609
Correspondent Contact Kaelan Sarin
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received08/21/2026
Decision Date 10/16/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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