Cleared Traditional

Optina-4C (MHRC-C1N)

K250770 · Optina Diagnostics, Inc. · Ophthalmic

Sep 2025

Decision

175d

Days

Class 2

Risk

About This 510(k) Submission

K250770 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 September 4, 2025, 175 days after receiving the submission on March 13, 2025. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1120.

Submission Details

510(k) Number	K250770 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 13, 2025
Decision Date	September 04, 2025
Days to Decision	175 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF