510(k) Report

FDA applicant

Applied Optronics Corp.

South Plainfield, NJ4 decisions1996–19960 recalls

FDA records 4 decisions for Applied Optronics Corp. (South Plainfield, NJ) in 1996: 4 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). 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, general and plastic surgery panel, where it files most

How often FDA has decided Applied Optronics Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Applied Optronics Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Applied Optronics 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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