STELLARIS PC VISION ENHANCEMENT SYSTEM

Unit, Phacofragmentation

BAUSCH & LOMB

The following data is part of a premarket notification filed by Bausch & Lomb with the FDA for Stellaris Pc Vision Enhancement System.

Pre-market Notification Details

Device IDK133486
510k NumberK133486
Device Name:STELLARIS PC VISION ENHANCEMENT SYSTEM
ClassificationUnit, Phacofragmentation
Applicant BAUSCH & LOMB 3365 TREE CT. INDUSTRIAL BLVD St. Louis,  MO  63122
ContactTimothy W Capehart
CorrespondentTimothy W Capehart
BAUSCH & LOMB 3365 TREE CT. INDUSTRIAL BLVD St. Louis,  MO  63122
Product CodeHQC  
Subsequent Product CodeHQE
Subsequent Product CodeHQF
CFR Regulation Number886.4670 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-11-13
Decision Date2014-03-12
Summary:summary

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