FDA applicant
Applied Optronics Corp.
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
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.
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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