FDA applicant
Led Spa
FDA records 1 decision for Led Spa (Aprilia, IT) in 2022: 1 510(k) clearance. All are in product code GEI (Electrosurgical, Cutting & Coagulation &…). 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 Led Spa’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2022high 1 (2022) · low 0 (2023)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2022.
Planning a device like Led Spa’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