# OUH: Skin Resurfacing Rf Applicator

- Device class: 2; regulation: 21 CFR 878.4400; FDA's rule: 510(k) required
- FDA decisions: 5
- Recalls: 1 (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)
- 2011: 1
- 2012: 1
- 2014: 1
- 2015: 1
- 2016: 1

## Most-cited predicates
- K101510: Fractional Skin Resurfacing (FSR) Applicator (2011), cited by 5
- K130501: Intensif (2014), cited by 4
- K120513: Glow by Endymed (2012), cited by 2
- K150409: VIVACE Electrosurgical System (2016), cited by 2

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