FDA applicant
Optacryl, Inc.
FDA records 4 decisions for Optacryl, Inc. (Walker, MI) from 1981 to 1982: 4 510(k) clearances. All are in product code HPX (Lens, Contact (Polymethylmethacrylate)). 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 Optacryl, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Optacryl, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Optacryl, 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