# PAY: Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction

- Device class: 2; regulation: 21 CFR 878.4420; FDA's rule: 510(k) required
- FDA decisions: 12
- 510(k) review time 2021–2025: median 224 days (middle half 157–313)
- 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)
- 2015: 1
- 2017: 1
- 2019: 1
- 2021: 1
- 2023: 3
- 2024: 3
- 2025: 1
- 2026: 1

## Most-cited predicates
- DEN150005: Newa Skin Therapy System (2015), cited by 3
- K220322: Pollogen STOP U Model UXV Device (2023), cited by 3
- K203665: STOP U Model UXV Device (2021), cited by 1
- K170499: sensiLift (2017), cited by 1
- K182774: STOP U (Packed Black USA), STOP U (Packed White USA) (2019), cited by 1

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