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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 K133242
Device Name STELLARIS VISION ENHANCEMENT SYSTEM
Applicant
Bausch & Lomb
3365 Tree Court Industrial Blv
St Louis,  MO  63122
Applicant Contact TIMOTHY W CAPEHART
Correspondent
Bausch & Lomb
3365 Tree Court Industrial Blv
St Louis,  MO  63122
Correspondent Contact TIMOTHY W CAPEHART
Regulation Number886.4670
Classification Product Code
HQC  
Subsequent Product Code
HQE  
Date Received10/21/2013
Decision Date 02/14/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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