FDA applicant
Smartlight, Ltd.
FDA records 2 decisions for Smartlight, Ltd. (Nesher, IL) from 1997 to 1999: 2 510(k) clearances. All are in product code IXC (Illuminator, Radiographic-Film). Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Smartlight, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Smartlight, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Smartlight, Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Smartlight, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report