Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens

Lens, Contact, Polymethylmethacrylate, Diagnostic

Volk Optical Inc.

The following data is part of a premarket notification filed by Volk Optical Inc. with the FDA for Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens.

Pre-market Notification Details

Device IDK151961
510k NumberK151961
Device Name:Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens
ClassificationLens, Contact, Polymethylmethacrylate, Diagnostic
Applicant Volk Optical Inc. 7893 Enterprise Drive Mentor,  OH  44060
ContactMeghan M Leonard
CorrespondentMeghan M Leonard
Volk Optical Inc. 7893 Enterprise Drive Mentor,  OH  44060
Product CodeHJK  
CFR Regulation Number886.1385 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-07-16
Decision Date2015-08-18
Summary:summary

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