510(k) Report

FDA applicant

Art Optical Contact Lens, Inc.

Walker, MI6 decisions2008–20230 recalls

FDA records 6 decisions for Art Optical Contact Lens, Inc. (Walker, MI) from 2008 to 2023: 6 510(k) clearances. Most are in product codes LPL (Lenses, Soft Contact, Daily Wear) and HQD (Lens, Contact (Other Material) - Daily). Its devices cite 8 predicates, 4 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 Art Optical Contact Lens, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2008: 12010: 12015: 22017: 12023: 1
2008high 2 (2015) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Art Optical Contact Lens, Inc. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Art Optical Contact Lens, Inc.’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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