# NTN: Led Light Source

- Device class: 2; regulation: 21 CFR 876.1500; FDA's rule: 510(k) exempt
- FDA decisions: 9
- 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)
- 2009: 2
- 2010: 1
- 2011: 1
- 2012: 2
- 2013: 1
- 2014: 1
- 2015: 1

## Most-cited predicates
- K122831: Video System Center (2012), cited by 3
- K091829: PLS Portable Light Source (2009), cited by 3
- K113679: Lucea Led Surgical Light System (2012), cited by 2
- K102167: LO-50 Led Light Source (2010), cited by 2
- K103813: SOPRO 281 (2011), cited by 1
- K130819: CLL- V1 Light Source (2013), cited by 1

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