510(k) Report

FDA applicant

American Optical Corp.

Mchenry, IL35 decisions1976–19950 recalls

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, last Nov 3, 2026

FIG. A — Illustration, ophthalmic panel, where it files most

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.

FIG. 1 — American Optical Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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.

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