Cleared Special

Optina-4C (MHRC-C1N)

K231230 · Optina Diagnostics, Inc. · Ophthalmic

Dec 2023

Decision

221d

Days

Class 2

Risk

About This 510(k) Submission

K231230 is an FDA 510(k) clearance for the Optina-4C (MHRC-C1N), a Camera, Ophthalmic, Ac-powered (Class II — Special Controls, product code HKI), submitted by Optina Diagnostics, Inc. (Montreal, CA). The FDA issued a Cleared decision on December 5, 2023, 221 days after receiving the submission on April 28, 2023. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1120.

Submission Details

510(k) Number	K231230 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 28, 2023
Decision Date	December 05, 2023
Days to Decision	221 days
Submission Type	Special
Review Panel	Ophthalmic (OP)
Summary	Summary PDF