VibrantVue Scleral Saline— 510(k) K201069

Name: FDA 510(k) clearance K201069
Creator: U.S. Food and Drug Administration
Published: 2020-07-31

Substantially Equivalent

Dry Eye Innovations, LLC

FDA 510(k) clearance K201069 for VibrantVue Scleral Saline, Substantially Equivalent on 2020-07-31. Applicant: Dry Eye Innovations, LLC. Device class: 2.

Clearance details

Applicant: Dry Eye Innovations, LLC
Product code: Code MRC
Device class: Class 2
Regulation: 21 CFR 886.5918
Advisory panel: Ophthalmic
Date received: 2020-04-22
Decision date: 2020-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oak Brook, IL, US

Download summary PDF View on FDA.gov ↗

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