BAUSCH + LUMB, VIS100 INJECTOR SYSTEM

Folders And Injectors, Intraocular Lens (iol)

BAUSCH & LOMB

The following data is part of a premarket notification filed by Bausch & Lomb with the FDA for Bausch + Lumb, Vis100 Injector System.

Pre-market Notification Details

Device IDK133146
510k NumberK133146
Device Name:BAUSCH + LUMB, VIS100 INJECTOR SYSTEM
ClassificationFolders And Injectors, Intraocular Lens (iol)
Applicant BAUSCH & LOMB 50 TECHNOLOGY DRIVE Irvine,  CA  92618
ContactShivani K Chitalia
CorrespondentShivani K Chitalia
BAUSCH & LOMB 50 TECHNOLOGY DRIVE Irvine,  CA  92618
Product CodeMSS  
CFR Regulation Number886.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-10-17
Decision Date2014-01-03
Summary:summary

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