PAYClass II
Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction
21 CFR 878.4420 / General, Plastic Surgery
PAY is the FDA product code for Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction, a class II device type, regulated under 21 CFR 878.4420. FDA's definition for this code reads: "An electrosurgical device for over-the-counter aesthetic use is a device using radiofrequency energy to produce localized heating within tissues for non-invasive aesthetic use". As of , FDA records hold 12 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- PAY
- Device name
- Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction
- FDA definition
- An electrosurgical device for over-the-counter aesthetic use is a device using radiofrequency energy to produce localized heating within tissues for non-invasive aesthetic use.
- Regulation
- 21 CFR 878.4420
- Device class
- Class II
- Review panel
- General, Plastic Surgery
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 12
- Ingested recalls
- 0
Clearances, product code PAY
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2015 | 1 |
| 2017 | 1 |
| 2019 | 1 |
| 2021 | 1 |
| 2023 | 3 |
| 2024 | 3 |
| 2025 | 1 |
| 2026 | 1 |
Applicants with the most clearances
Product code PAY| Applicant | Clearances |
|---|---|
| Pollogen Ltd | 5 |
| El Global Trade Ltd. | 3 |
| Foreo Inc | 2 |
| Endymed Medical Inc. | 1 |
| Silk'n Beauty Ltd. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.