Optina-4C (MHRC-C1N)

FDA 510(k) K231230 · Optina Diagnostics, Inc.

Substantially Equivalent

510(k) numberK231230

Submission

Device name
Optina-4C (MHRC-C1N)
Applicant
Optina Diagnostics, Inc.
Montreal, CA
Received
April 28, 2023
Decision date
December 5, 2023
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HKI – Camera, Ophthalmic, Ac-Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 886.1120
Specialty
Ophthalmic

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Questions and answers

When was Optina-4C (MHRC-C1N) cleared by the FDA?

Optina-4C (MHRC-C1N) (K231230) received a 510(k) decision of Substantially Equivalent on December 5, 2023, 221 days after the submission was received.

What is the product code of K231230?

The FDA product code is HKI – Camera, Ophthalmic, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1120.