FDA applicant
Ultralite
FDA records 6 decisions for Ultralite (Walker, MI) from 1977 to 1991: 6 510(k) clearances. Most are in product codes FTC (Light, Ultraviolet, Dermatological) and KGL (Cabinet, Phototherapy (Puva)). 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 Ultralite’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Ultralite since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Ultralite’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