510(k) Report

FDA applicant

Optimark Accessories and Instruments

Seattle, WA1 decision1994–19940 recalls

FDA records 1 decision for Optimark Accessories and Instruments (Seattle, WA) in 1994: 1 510(k) clearance. All are in product code 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 Optimark Accessories and Instruments’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Optimark Accessories and Instruments since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Optimark Accessories and Instruments’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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