# NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes

- Device class: 2; regulation: 21 CFR 882.5890; FDA's rule: 510(k) required
- FDA decisions: 83
- 510(k) review time 2021–2025: median 128 days (middle half 73–209)
- 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)
- 2017: 7
- 2018: 5
- 2019: 3
- 2020: 2
- 2021: 7
- 2022: 2
- 2023: 8
- 2024: 5
- 2025: 16
- 2026: 8

## Most-cited predicates
- K103472: Nuface Plus (2011), cited by 10
- K171821: 2 Face / Face Evolution (2018), cited by 9
- K072260: Nuface, Model NU-4003 (2007), cited by 8
- K233010: Beagank 4T Plus (2023), cited by 7
- K011935: Rejuvenique Model #RJV10 (2001), cited by 6
- K221443: PureLift Pro Plus (2022), cited by 6
- K130065: Beautiful Image Facial Sculpting Device (2014), cited by 5
- K040871: Facemaster Facial Toning System (2005), cited by 4
- K171588: NuBODY Skin Toning Device (2017), cited by 4
- K181008: NuFACE Trinity (2018), cited by 4

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