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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
Recalls CDRH Recalls
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