# FTC: Light, Ultraviolet, Dermatological

- Device class: 2; regulation: 21 CFR 878.4630; FDA's rule: 510(k) required
- FDA decisions: 274
- 510(k) review time 2021–2025: median 81 days (middle half 49–89)
- Recalls: 10 (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)
- 2017: 2
- 2018: 3
- 2019: 2
- 2020: 5
- 2021: 3
- 2022: 1
- 2023: 4
- 2024: 1
- 2025: 3
- 2026: 4

## Most-cited predicates
- K020591: Bclear (2002), cited by 9
- K033946: Lovely System (2004), cited by 9
- K022165: Theralight UV120-2 Uva/Uvb Phototherapy System, Model UV120-2 (2002), cited by 7
- K050695: Flex Controlled Phototherapy Equipment (2005), cited by 6
- K024020: Theralight UV120-2 Uva/Uvb Phototherapy System (2003), cited by 6
- K021762: Bclear (2002), cited by 5
- K041212: Houva 3 Phototherapy System (2004), cited by 4
- K073587: Dermapal with Digital Timer (2008), cited by 4
- K172273: 308nm Excimer System (2018), cited by 4
- K063621: 3 Series Phototherapy Cabinet (2007), cited by 4

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