PAY — Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction Class II
FDA product code PAY covers "Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction", a Class II medical device regulated under 21 CFR 878.4420. Submissions are reviewed by the General, Plastic Surgery panel. At least 12 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PAY
- Device Class
- Class II
- Regulation Number
- 878.4420
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250341 | el global trade | Sensilift Pro (ST300XXYYZZZ) | January 6, 2026 |
| K242227 | pollogen | GENEO X ELITE | October 12, 2025 |
| K240616 | foreo | FAQ (102) | July 15, 2024 |
| K233766 | pollogen | Geneo X Elite | May 7, 2024 |
| K232424 | el global trade | CurrentBody Skin RF | March 6, 2024 |
| K230013 | silk'n beauty | Silk'n Titan Allways | August 30, 2023 |
| K220322 | pollogen | Pollogen STOP U Model UXV Device | May 4, 2023 |
| K222012 | foreo | FAQ 101 | April 5, 2023 |
| K203665 | pollogen | STOP U Model UXV Device | February 25, 2021 |
| K182774 | pollogen | STOP U (Packed Black USA), STOP U (Packed White USA) | June 19, 2019 |
| K170499 | el global trade | sensiLift | June 15, 2017 |
| DEN150005 | endymed medical | Newa Skin Therapy System | December 18, 2015 |