510(k) Report

FDA applicant

Ocular Concepts, LLC

Lake Oswego, OR1 decision2000–20000 recalls

FDA records 1 decision for Ocular Concepts, LLC (Lake Oswego, OR) in 2000: 1 510(k) clearance. All are in product code NCK (Button, Iris, Eye, Artificial). 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 Ocular Concepts, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ocular Concepts, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Ocular”

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