Cleared Traditional

UniVit HE, UniVit UHS

K212763 · Visioncare Devices, LLC · Ophthalmic

Aug 2022

Decision

344d

Days

Class 2

Risk

About This 510(k) Submission

K212763 is an FDA 510(k) clearance for the UniVit HE, UniVit UHS, a Instrument, Vitreous Aspiration And Cutting, Ac-powered (Class II — Special Controls, product code HQE), submitted by Visioncare Devices, LLC (Anderson, US). The FDA issued a Cleared decision on August 10, 2022, 344 days after receiving the submission on August 31, 2021. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4150.

Submission Details

510(k) Number	K212763 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 31, 2021
Decision Date	August 10, 2022
Days to Decision	344 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF