FDA applicant
American Optical Corp.
FDA records 35 decisions for American Optical Corp. (Mchenry, IL) from 1976 to 1995: 35 510(k) clearances. Most are in product codes HQC (Unit, Phacofragmentation) and HQG (Lens, Spectacle, Non-Custom (Prescription)). 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 American Optical Corp.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for American Optical Corp. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like American Optical Corp.’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