FDA applicant
Slt-J, Ltd.
FDA records 3 decisions for Slt-J, Ltd. (Milford, OH) in 1996: 3 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 9 predicates, 0 of them its own earlier devices. 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 Slt-J, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Slt-J, Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Slt-J, Ltd.’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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