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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 K181796
Device Name FreshLook Handling Tint, FreshLook Colors, FreshLook ColorBlends, FreshLook Dimensions
Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth,  TX  76134 -2099
Applicant Contact Sherri Lakota
Alcon/CIBA Vision GmbH
Industriering 1
Grosswallstadt,  DE 63868
Correspondent Contact Andreas Friese
Regulation Number886.5925
Classification Product Code
Date Received07/05/2018
Decision Date 08/03/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No