FDA applicant

Kowa Optimed, Inc.

Washington, DC10 decisions1988–20020 recalls

FDA records 10 decisions for Kowa Optimed, Inc. (Washington, DC) from 1988 to 2002: 10 510(k) clearances. Most are in product codes HKI (Camera, Ophthalmic, Ac-Powered) and HJO (Biomicroscope, Slit-Lamp, Ac-Powered). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ophthalmic panel, where it files most

How often FDA has decided Kowa Optimed, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Kowa Optimed, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Kowa Optimed, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Kowa”

FDA records each applicant name separately; these may or may not be the same firm.

Kowa Co., Ltd. 19 Kowa Co. Ltd. Chofu 1 Kowa Company, Ltd. Chofu Factory 1

Kowa Optimed, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Kowa”