Optina-4C (MHRC-C1N)

FDA 510(k) K250770 · Optina Diagnostics, Inc.

Substantially Equivalent

510(k) numberK250770

Submission

Device name
Optina-4C (MHRC-C1N)
Applicant
Optina Diagnostics, Inc.
Montreal, CA
Received
March 13, 2025
Decision date
September 4, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 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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More from Zilia, Inc.

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Questions and answers

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

Optina-4C (MHRC-C1N) (K250770) received a 510(k) decision of Substantially Equivalent on September 4, 2025, 175 days after the submission was received.

What is the product code of K250770?

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