# OUP: Powered Surgical Instrument For Improvement In The Appearance Of Cellulite

- Device class: 2; regulation: 21 CFR 878.4790; FDA's rule: 510(k) required
- FDA decisions: 9
- 510(k) review time 2021–2025: median 81 days (middle half 56–85)
- 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)
- 2013: 1
- 2014: 1
- 2015: 1
- 2016: 2
- 2019: 1
- 2021: 1
- 2022: 1
- 2023: 1

## Most-cited predicates
- K212399: Aveli (2021), cited by 1
- K134010: Cabochon System (2014), cited by 1
- K192185: The Cellfina System (2019), cited by 1
- K161885: The Cellfina System (2016), cited by 1
- K153677: The Cellfina System (2016), cited by 1
- K221336: Avéli (2022), cited by 1
- K150505: Cellfina System (2015), cited by 1
- DEN110004: Cabochon System (2013), cited by 1

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