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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 K233856
Device Name Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 Multifocal
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 Received12/05/2023
Decision Date 12/29/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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