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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 K181454
Device Name DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech, DAILIES AquaComfort Plus Toric and DAILIES AquaComfort Plus Multifocal
Applicant
Alcon Laboratories, Inc.
6201 S. Fwy.
Fort Worth,  TX  76134
Applicant Contact Sherri Lakota
Correspondent
Alcon Laboratories, Inc.
6201 S. Fwy.
Fort Worth,  TX  76134
Correspondent Contact Katryna Warren
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received06/04/2018
Decision Date 11/21/2018
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
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