FDA Product Code PAY: Over-the-counter Radiofrequency Coagulation Device For Wrinkle Reduction
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.
Leading manufacturers include Pollogen, Ltd., Foreo, Inc. and El Global Trade, Ltd..
FDA 510(k) Cleared Over-the-counter Radiofrequency Coagulation Device For Wrinkle Reduction Devices (Product Code PAY)
About Product Code PAY - Regulatory Context
510(k) Submission Activity
12 total 510(k) submissions under product code PAY since 2015, with 11 receiving FDA clearance (average review time: 252 days).
Submission volume has declined in recent years - 3 submissions in the last 24 months compared to 5 in the prior period.
FDA Review Time
Recent submissions under PAY have taken an average of 302 days to reach a decision - up from 236 days historically. Manufacturers should account for longer review timelines in current project planning.
PAY devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →