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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 K120732
Device Name LENSSX LASER SYSTEM
Applicant
Alcon Lensx, Inc.
733 Bolsana Dr.
Laguna Beach,  CA  92651
Applicant Contact Judy Gordon
Correspondent
Alcon Lensx, Inc.
733 Bolsana Dr.
Laguna Beach,  CA  92651
Correspondent Contact Judy Gordon
Regulation Number886.4670
Classification Product Code
HQC  
Subsequent Product Codes
HNO   OOE  
Date Received03/09/2012
Decision Date 09/06/2012
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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