FDA applicant
Sunbronze
FDA records 3 decisions for Sunbronze (St. Louis, MO) from 1989 to 1990: 3 510(k) clearances. Most are in product codes LEJ (Booth, Sun Tan) and FTC (Light, Ultraviolet, Dermatological). 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 Sunbronze’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Sunbronze since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Sunbronze’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