FDA applicant

Optek Medico Co., Ltd.

Chiyoda-Ku Tokyo Japan, JP3 decisions1984–19860 recalls

FDA records 3 decisions for Optek Medico Co., Ltd. (Chiyoda-Ku Tokyo Japan, JP) from 1984 to 1986: 3 510(k) clearances. Most are in product codes HJO (Biomicroscope, Slit-Lamp, Ac-Powered) and HPC (Set, Lens, Trial, Ophthalmic). 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 Optek Medico Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Optek Medico Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Optek Medico Co., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Optek Medico Co., Ltd.

Which product codes does it file in?

What has FDA decided for it lately?