# ONQ: Electrosurgical Coagulation For Aesthetic

- Device class: 2; regulation: 21 CFR 878.4400; FDA's rule: 510(k) required
- FDA decisions: 4
- 510(k) review time 2021–2025: median 339 days (middle half 339–339)
- 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: 1
- 2012: 1
- 2013: 1
- 2021: 1

## Most-cited predicates
- K083352: Veinwave, TC3000 (2009), cited by 3
- K130283: Evrf System (2013), cited by 1
- K210077: MED RF 4000 (2021), cited by 1

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