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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 K133486
Device Name STELLARIS PC VISION ENHANCEMENT SYSTEM
Applicant
Bausch & Lomb
3365 Tree Ct. Industrial Blvd.
St. Louis,  MO  63122
Applicant Contact TIMOTHY W CAPEHART
Correspondent
Bausch & Lomb
3365 Tree Ct. Industrial Blvd.
St. Louis,  MO  63122
Correspondent Contact TIMOTHY W CAPEHART
Regulation Number886.4670
Classification Product Code
HQC  
Subsequent Product Codes
HQE   HQF  
Date Received11/13/2013
Decision Date 03/12/2014
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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