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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Phacofragmentation
510(k) Number K233876
Device Name UNITY VCS (8065000296); UNITY CS (8065000297)
Applicant
Alcon Laboratories, Inc.
6201 S. Fwy.
Fort Worth,  TX  76134
Applicant Contact Ganesh Balachandar
Correspondent
Alcon Laboratories, Inc.
6201 S. Fwy.
Fort Worth,  TX  76134
Correspondent Contact Ganesh Balachandar
Regulation Number886.4670
Classification Product Code
HQC  
Subsequent Product Codes
HQE   HQF  
Date Received12/07/2023
Decision Date 06/21/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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