# NVK: Laser, Dental, Soft Tissue

- Device class: 2; regulation: 21 CFR 878.4810; FDA's rule: 510(k) required
- FDA decisions: 17
- 510(k) review time 2021–2025: median 191 days (middle half 128–282)
- Recalls: 2 (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)
- 2005: 1
- 2021: 4
- 2022: 5
- 2023: 1
- 2024: 2
- 2025: 2
- 2026: 2

## Most-cited predicates
- K210367: D-Laser Blue, D-Laser 16 (2022), cited by 4
- K030146: Kavo Key Laser 1242 and Kavo Key Laser 1243+ (2005), cited by 3
- K203396: Deka Smartperio (2021), cited by 1
- K230047: Medical Diode Laser Systems (2024), cited by 1
- K210350: Gemini 2 810+980 Soft Tissue Laser (2021), cited by 1

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