Home / 510(k) Clearances / K202097

510(k) K202097

Fundus Camera by Huvitz Co., Ltd. — Product Code HKI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 2021
Date Received
July 29, 2020
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 Huvitz Co., Ltd.

  • K232143 — Applanation Tonometer HT-5000 (October 23, 2023)
  • K191615 — Huvitz Imaging System (July 18, 2019)
  • K161829 — Huvitz Imaging System (April 6, 2017)
  • K093639 — SLIT LAMP, MODELS HS-5000, HS-5500 AND HS-7500 (December 3, 2009)
  • K073190 — SLIT LAMP (January 11, 2008)

Other clearances for product code HKI

  • K251353 — Eyer 2 (January 16, 2026)
  • K252120 — Fundus On Phone Non Mydriatic (FOP NM-10) (December 12, 2025)
  • K250770 — Optina-4C (MHRC-C1N) (September 4, 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)