Bausch + Lomb Injector System

Folders And Injectors, Intraocular Lens (iol)

Bausch & Lomb, Inc.

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

Pre-market Notification Details

Device IDK151102
510k NumberK151102
Device Name:Bausch + Lomb Injector System
ClassificationFolders And Injectors, Intraocular Lens (iol)
Applicant Bausch & Lomb, Inc. 50 Technology Drive Irvine,  CA  92618
ContactJoyce Zhong
CorrespondentJoyce Zhong
Bausch & Lomb, Inc. 50 Technology Drive Irvine,  CA  92618
Product CodeMSS  
CFR Regulation Number886.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-04-24
Decision Date2015-05-22
Summary:summary

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