510(k) Report

FDA applicant

Sunbronze

St. Louis, MO3 decisions1989–19900 recalls

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, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

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.

FIG. 1 — Sunbronze by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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