# NUV: Massager, Vacuum, Light Induced Heating

- Device class: 2; regulation: 21 CFR 878.4810; FDA's rule: 510(k) required
- FDA decisions: 20
- 510(k) review time 2021–2025: median 107 days (middle half 81–132)
- 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: 4
- 2010: 2
- 2011: 1
- 2012: 1
- 2013: 1
- 2017: 1
- 2019: 1
- 2021: 1
- 2023: 1
- 2026: 1

## Most-cited predicates
- K050397: Velasmooth, Shaper (2005), cited by 8
- K071872: Velashape (2007), cited by 7
- K090221: Reaction System (2009), cited by 7
- K082622: Alma Lasers Accent B-Shape Massager Handpiece/Module (2009), cited by 5
- K122579: Velashape (2012), cited by 4
- K053611: Smoothshapes (2006), cited by 4
- K061603: Smoothshapes (2006), cited by 3
- K070092: Modification to Velasmooth, Shaper (2007), cited by 3
- K131362: Inmode Wmbody Device (2013), cited by 3
- K101147: Modified Alma Lasers Family of Accent Radiofrequency (RF) System (2011), cited by 2

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