# LEJ: Booth, Sun Tan

- Device class: 2; regulation: 21 CFR 878.4635; FDA's rule: 510(k) required
- FDA decisions: 81
- 510(k) review time 2021–2025: median 197 days (middle half 163–231)
- Recalls: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1993: 4
- 1994: 7
- 2009: 1
- 2015: 9
- 2016: 11
- 2017: 1
- 2018: 6
- 2019: 3
- 2022: 1
- 2023: 1

## Most-cited predicates
- K151400: Ergoline, Sun Angel, Soltron, Sundash and Palm Beach Tan Sunlamp Products (2015), cited by 4
- K944015: Harpo Sunbed, Sun Tanning Machine (1994), cited by 2
- K190173: Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid Technology / AC / Sound, Ergoline Planet Fitness 42/4 Hybrid Light Technology / Sound (2019), cited by 1
- K152405: IBL 5000 Tanning Booth (2016), cited by 1
- K143043: Tanning Lamp (2015), cited by 1
- K151370: UV Lamps for Indoor Tanning Devices (2015), cited by 1
- K151962: KBL Sunlamp Products (= Device Bundling name) (2016), cited by 1
- K151674: Ultraviolet Sun Tanning Lamp (2015), cited by 1
- K152233: BPhase, HPO Exotic, LPI, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux (2016), cited by 1
- K152273: Cosmedico Ultraviolet Lamps of Various Models (2015), cited by 1

Source page: https://510kreport.com/product-code/LEJ
Data by year (CSV): https://510kreport.com/product-code/LEJ.csv