FDA applicant
Curelight, Ltd.
FDA records 6 decisions for Curelight, Ltd. (Washington, DC) from 2002 to 2004: 6 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 4 predicates, 1 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 Curelight, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Curelight, Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Curelight, 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