FDA applicant

Oculo-Plastik Reg'D

Canada, CA1 decision1987–19870 recalls

FDA records 1 decision for Oculo-Plastik Reg'D (Canada, CA) in 1987: 1 510(k) clearance. All are in product code HPZ (Implant, Eye Sphere). 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 Oculo-Plastik Reg'D’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Oculo-Plastik Reg'D since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Oculo-Plastik Reg'D by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Oculo-Plastik Reg'D’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Oculo-Plastik”

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

Oculo Plastik, Inc. 13

Oculo-Plastik Reg'D

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Oculo-Plastik”