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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 K161391
Device Name DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DACP Multifocal, Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives
Applicant
ALCON LABORATORIES, INC.
6201 SOUTH FREEWAY
FORT WORTH,  TX  76134 -2099
Applicant Contact Sherri Lakota
Correspondent
ALCON / CIBA VISION GMBH
INDUSTRIERING 1
Grosswallstadt,  DE 63868
Correspondent Contact Andreas Friese
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received05/19/2016
Decision Date 11/30/2016
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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