PAY — Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction Class II
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 |