PAY

Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction

Product code

PAY

Device name

Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction

Device class

Class 2

21 CFR

21 CFR 878.4420

Medical specialty

General, Plastic Surgery

Marketing pathway

510(K)

510(k) clearances (last 3 years)

12

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (5)

Last three years. Most recent: 2026-01-06.

2 summaries are archived here for direct download.