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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Contact, (Disposable)
510(k) Number K202036
Device Name Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal
Applicant
Alcon Laboratories, Inc.
6201 S. 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
MVN  
Subsequent Product Code
LPL  
Date Received07/23/2020
Decision Date 08/21/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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