# ONE: Powered Light Based Non-Laser Surgical Instrument

- Device class: 2; regulation: 21 CFR 878.4810; FDA's rule: 510(k) required
- FDA decisions: 7
- 510(k) review time 2021–2025: median 81 days (middle half 81–81)
- Recalls: 0 (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)
- 2010: 4
- 2011: 1
- 2017: 1
- 2025: 1

## Most-cited predicates
- K171055: Philips BlueControl (2017), cited by 1
- K092800: Anti-Wrinkle (Aging) Light, Model Aal (2010), cited by 1

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