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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 K232921
Device Name DAILIES TOTAL1®; DAILIES TOTAL1® Toric; DAILIES TOTAL1® Multifocal; DAILIES TOTAL1® Multifocal Toric
Applicant
Alcon Laboratories, Inc.
6201 S. Freeway
Fort Worth,  TX  76134 -2099
Applicant Contact Martina Heim
Correspondent
Alcon Laboratories, Inc.
6201 S. Freeway
Fort Worth,  TX  76134 -2099
Correspondent Contact Martina Heim
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received09/19/2023
Decision Date 11/16/2023
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
Recalls CDRH Recalls
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