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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 K254052
Device Name DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal
Applicant
Alcon Laboratories, Inc.
6201 S. Freeway
Fort Worth,  TX  76134 -2099
Applicant Contact Andreas Friese
Correspondent
Alcon Laboratories, Inc.
6201 S. Freeway
Fort Worth,  TX  76134 -2099
Correspondent Contact Andreas Friese
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received12/17/2025
Decision Date 02/13/2026
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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