FDA applicant
Art Optical Contact Lens, Inc.
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
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
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2008.
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.
See the 510(k) Report