# NXV: Diagnostic Light, Soft Tissue Detector

- Device class: 2; regulation: 21 CFR 872.6350; FDA's rule: 510(k) required
- FDA decisions: 12
- 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)
- 2006: 1
- 2007: 1
- 2008: 3
- 2009: 2
- 2010: 2
- 2012: 1
- 2013: 1
- 2015: 1

## Most-cited predicates
- K070523: Modification to: Velscope (2007), cited by 3
- K102083: Velscope VX (2010), cited by 2
- K090135: Trimira Identafi 3000 (2009), cited by 2
- K060920: Velscope (2006), cited by 2
- K101140: Dentlight Oral Exam Light Kit (2010), cited by 2
- K073483: Sapphire O/E Oral Examination System (2008), cited by 1
- K080043: Vizilite Eyewear (2008), cited by 1
- K082603: Trimira Ocs 3000 (2008), cited by 1

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