Home / 510(k) Clearances / K083771

510(k) K083771

RETCAM PORTABLE OPHTHALMIC IMAGING SYSTEM, MODEL RCP by Clarity Medical Systems — Product Code HKI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 2009
Date Received
December 18, 2008
Clearance Type
Special
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 Clarity Medical Systems

  • K102859 — RETCAM 3 OPTHALMIC IMAGING SYSTEM (April 20, 2011)
  • K090326 — RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMS (November 25, 2009)
  • K081858 — RETCAM 3 OPHTHALMIC IMAGING SYSTEM (November 5, 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)