FDA applicant

Optikem International, Inc.

Walker, MI2 decisions1982–20070 recalls

FDA records 2 decisions for Optikem International, Inc. (Walker, MI) from 1982 to 2007: 2 510(k) clearances. Most are in product codes HPX (Lens, Contact (Polymethylmethacrylate)) and LPN (Accessories, Soft Lens Products). Its devices cite 1 predicate, 0 of them its own earlier devices. 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 Optikem International, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Optikem International, 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 “Optikem”

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

Optikem Polymers, Inc. 1

Optikem International, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Optikem”