FDA applicant
American Medical Optics
FDA records 17 decisions for American Medical Optics (Walker, MI) from 1982 to 1986: 17 510(k) clearances. Most are in product codes HQF (Laser, Ophthalmic) and HLI (Ophthalmoscope, Ac-Powered). 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 Medical Optics’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for American Medical Optics since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like American Medical Optics’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