FDA applicant

Atlantic Optical Systems, Inc.

Leechburg, PA4 decisions1983–19850 recalls

FDA records 4 decisions for Atlantic Optical Systems, Inc. (Leechburg, PA) from 1983 to 1985: 4 510(k) clearances. Most are in product codes HQC (Unit, Phacofragmentation) and HQE (Instrument, Vitreous Aspiration And Cutting…). 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 Atlantic Optical Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Atlantic Optical Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Atlantic Optical Systems, Inc.

Which product codes does it file in?

What has FDA decided for it lately?