Cleared Traditional

VibrantVue Scleral Saline

K201069 · Dry Eye Innovations, LLC · Ophthalmic

Jul 2020

Decision

100d

Days

Class 2

Risk

About This 510(k) Submission

K201069 is an FDA 510(k) clearance for the VibrantVue Scleral Saline, a Products, Contact Lens Care, Rigid Gas Permeable (Class II — Special Controls, product code MRC), submitted by Dry Eye Innovations, LLC (Oak Brook, US). The FDA issued a Cleared decision on July 31, 2020, 100 days after receiving the submission on April 22, 2020. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5918.

Submission Details

510(k) Number	K201069 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 22, 2020
Decision Date	July 31, 2020
Days to Decision	100 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF