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510(k) K250770

Optina-4C (MHRC-C1N) by Optina Diagnostics, Inc. — Product Code HKI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 2025
Date Received
March 13, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, Ophthalmic, Ac-Powered
Device Class
Class II
Regulation Number
886.1120
Review Panel
OP
Submission Type

Other clearances by Optina Diagnostics, Inc.

  • K231230 — Optina-4C (MHRC-C1N) (December 5, 2023)
  • K200254 — Mydriatic Hyperspectral Retinal Camera (MHRC-C1) (April 27, 2020)

Other clearances for product code HKI

  • K251353 — Eyer 2 (January 16, 2026)
  • K252120 — Fundus On Phone Non Mydriatic (FOP NM-10) (December 12, 2025)
  • K243600 — 3nethra neo HD FA; 3nethra neo HD (August 14, 2025)
  • K250683 — Resolve Fundus Camera (April 30, 2025)
  • K243664 — Sentinel Camera (December 17, 2024)
  • K242508 — Verily Numetric Retinal Camera (December 9, 2024)
  • K241049 — CANON Fundus Camera CR-10 (CR-10) (May 15, 2024)
  • K231230 — Optina-4C (MHRC-C1N) (December 5, 2023)
  • K230627 — Zilia Ocular FC (ZIL-10002) (November 20, 2023)
  • K223575 — Phoenix ICON, Phoenix ICON GO (September 6, 2023)