FDA product code PAY: Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction
PAY is the FDA product code for over-the-counter radiofrequency coagulation device for wrinkle reduction. It is a Class II device, regulated under 21 CFR 878.4420 and reviewed by the General and Plastic Surgery panel. FDA has cleared 11 510(k) submissions under PAY, 8 in the last five years, from 4 different applicants. The average 510(k) review took 245 days (median 239); 314 days on average over the last three years. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction |
| Device class | Class II |
| Regulation | 21 CFR 878.4420 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
510(k) clearances per year for PAY
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 118 |
| 2019 | 1 | 261 |
| 2021 | 1 | 71 |
| 2023 | 3 | 322 |
| 2024 | 3 | 168 |
| 2025 | 1 | 439 |
| 2026 | 1 | 334 |
Compare with all 510(k) review times · Search every PAY clearance
Top PAY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Pollogen, Ltd. | 5 | 2025-10-12 |
| El Global Trade, Ltd. | 3 | 2026-01-06 |
| Foreo, Inc. | 2 | 2024-07-15 |
| Silk'N Beauty , Ltd. | 1 | 2023-08-30 |
Most recent PAY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250341 | El Global Trade, Ltd. | Sensilift Pro (ST300XXYYZZZ) | 2026-01-06 | 334 |
| K242227 | Pollogen, Ltd. | GENEO X ELITE | 2025-10-12 | 439 |
| K240616 | Foreo, Inc. | FAQ (102) | 2024-07-15 | 132 |
| K233766 | Pollogen, Ltd. | Geneo X Elite | 2024-05-07 | 165 |
| K232424 | El Global Trade, Ltd. | CurrentBody Skin RF | 2024-03-06 | 208 |
Recalls for PAY devices
openFDA lists no recalls for product code PAY.
Frequently asked questions
What is FDA product code PAY?
PAY is the FDA product code for over-the-counter radiofrequency coagulation device for wrinkle reduction. It is a Class II device, regulated under 21 CFR 878.4420 and reviewed by the General and Plastic Surgery panel.
What device class is PAY?
Class II, regulation 21 CFR 878.4420. Typical premarket route: 510(k).
How long does a 510(k) take for product code PAY?
Across 11 cleared submissions the average was 245 days from receipt to decision (median 239).
Which companies have the most PAY clearances?
Pollogen, Ltd. (5); El Global Trade, Ltd. (3); Foreo, Inc. (2); Silk'N Beauty , Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PAY
- Run a recall and safety report across every PAY manufacturer
- Watch product code PAY for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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