PAY
12 FDA 510(k) clearances · Product code
261 daysmedian time to decision
439 days90th percentile
12clearances measured
FDA profile
- Official device name
- Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4420
- Medical specialty
- General, Plastic Surgery
- 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Sensilift Pro (ST300XXYYZZZ) (K250341) | El Global Trade, Ltd. | 2026-01-06 |
| GENEO X ELITE (K242227) | Pollogen, Ltd. | 2025-10-12 |
| FAQ™ (102) (K240616) | Foreo, Inc. | 2024-07-15 |
| Geneo X Elite (K233766) | Pollogen, Ltd. | 2024-05-07 |
| CurrentBody Skin RF (K232424) | El Global Trade, Ltd. | 2024-03-06 |
| Silk'n Titan Allways (K230013) | Silk'N Beauty , Ltd. | 2023-08-30 |
| Pollogen STOP U Model UXV Device (K220322) | Pollogen, Ltd. | 2023-05-04 |
| FAQ 101 (K222012) | Foreo, Inc. | 2023-04-05 |
| STOP U Model UXV Device (K203665) | Pollogen, Ltd. | 2021-02-25 |
| STOP U (Packed Black USA), STOP U (Packed White USA) (K182774) | Pollogen, Ltd. | 2019-06-19 |
| sensiLift (K170499) | El Global Trade, Ltd. | 2017-06-15 |
| Newa Skin Therapy System (DEN150005) | Endymed Medical, Ltd. | 2015-12-18 |
Track PAY automatically
Every clearance here is in the API, with alerts when new ones post.