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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 K222500
Device Name AIR OPTIX COLORS
Applicant
Alcon Laboratories, Inc.
6201 S. Fwy.
Fort Worth,  TX  76134
Applicant Contact Sherri Lakota
Correspondent
Alcon / Ciba Vision GmbH
Industriering 1
Grosswallstadt,  DE 63868
Correspondent Contact Dr.Andreas Friese
Regulation Number886.5925
Classification Product Code
LPL  
Date Received08/18/2022
Decision Date 09/15/2022
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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