Stellaris Elite 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 Elite Vision Enhancement System.

Pre-market Notification Details

Device IDK162342
510k NumberK162342
Device Name:Stellaris Elite Vision Enhancement System
ClassificationUnit, Phacofragmentation
Applicant Bausch + Lomb 3365 Tree Ct. Industrial Blvd. St. Louis,  MO  63122
ContactKen Nehmer
CorrespondentKen Nehmer
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 Received2016-08-22
Decision Date2017-03-24
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.