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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 K162342
Device Name Stellaris Elite Vision Enhancement System
Applicant
Bausch+Lomb
3365 Tree Ct. Industrial Blvd.
St. Louis,  MO  63122
Applicant Contact Ken Nehmer
Correspondent
Bausch+Lomb
3365 Tree Ct. Industrial Blvd.
St. Louis,  MO  63122
Correspondent Contact Ken Nehmer
Regulation Number886.4670
Classification Product Code
HQC  
Subsequent Product Codes
HQE   HQF  
Date Received08/22/2016
Decision Date 03/24/2017
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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