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510(k) K083387

MODIFICATION TO KOWA NONMYD ALPHA-DIII by Kowa Co. , Ltd. — Product Code HKI

K083387 is an FDA 510(k) premarket notification submitted by Kowa Co. , Ltd. for the device "MODIFICATION TO KOWA NONMYD ALPHA-DIII". The FDA issued a decision of Substantially Equivalent on January 16, 2009. The device falls under product code HKI (Camera, Ophthalmic, Ac-Powered), a Class II device regulated under 21 CFR 886.1120. Kowa Co. , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 2009
Date Received
November 17, 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 Kowa Co. , Ltd.

  • K133755 — KOWA SL-17 (March 11, 2014)
  • K112330 — KOWA VX-20 (February 16, 2012)
  • K101628 — KOWA NONMYD WX (January 26, 2011)
  • K091098 — KOWAGENESIS-DF (August 7, 2009)
  • K091039 — KOWA, FM-600, MODEL LSS50 (August 7, 2009)
  • K091683 — KOWA VX-10 A (July 2, 2009)
  • K082767 — KOWA NONMYD ALPHA-DIII (October 21, 2008)
  • K080681 — KOWA GENESIS-D (April 4, 2008)
  • K063640 — KOWA SL-15 (December 18, 2006)
  • K062021 — KOWA VX-10I (November 1, 2006)

Other clearances for product code HKI

  • K253176 — TearView (June 22, 2026)
  • 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)

FDA data resources