Optina-4C (MHRC-C1N)— 510(k) K250770

Substantially Equivalent

Optina Diagnostics, Inc.

FDA 510(k) clearance K250770 for Optina-4C (MHRC-C1N), Substantially Equivalent on 2025-09-04. Applicant: Optina Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Optina Diagnostics, Inc.
Product code: Code HKI
Device class: Class 2
Regulation: 21 CFR 886.1120
Advisory panel: Ophthalmic
Date received: 2025-03-13
Decision date: 2025-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montreal, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code HKI

K253176 — TearView2026-06-22
K251353 — Eyer 22026-01-16
K252120 — Fundus On Phone Non Mydriatic (FOP NM-10)2025-12-12
K243600 — 3nethra neo HD FA2025-08-14
K250683 — Resolve Fundus Camera2025-04-30

More clearances from Optina Diagnostics, Inc.

K231230 — Optina-4C (MHRC-C1N)2023-12-05

Data sourced from openFDA. This site is unofficial and independent of the FDA.