FDA product code · General, Plastic Surgery · Class 2
PAY: Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction
PAY is FDA's product code for "Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction": a Class 2 device classified under 21 CFR 878.4420, reviewed by the General, Plastic Surgery panel.
510(k) review time for PAY
Across 10 510(k) clearances under PAY decided from 2018-01-01 to 2026-10-06, the median was 250 days from FDA receipt to decision. Half took between 176 and 318 days, and 80% were decided within 355 days. These are past clearances, not a forecast for a new submission.
| Fastest | 71 |
|---|---|
| 25th percentile | 176 |
| Median | 250 |
| 75th percentile | 318 |
| 80th percentile | 355 |
| 90th percentile | 441 |
| Slowest | 455 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
FDA-recognized standards that cite PAY
No FDA recognized consensus standard cites PAY by product code. Horizontal standards such as biocompatibility, sterilization and software standards can still apply.
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.