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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 K230785
Device Name Precision1, Precision1 for Astigmatism
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
LPL  
Date Received03/22/2023
Decision Date 04/20/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Clinical Trials NCT03305770
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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