DeviceClearance

Product code PAY— General, Plastic Surgery

CurrentBody Skin RF

Classification name
Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction
Device class
Class 2
Regulation
21 CFR 878.4420
Advisory panel
General, Plastic Surgery
Total cleared
12
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code PAY under 21 CFR 878.4420, via openFDA

Market context for product code PAY

FDA has cleared 12 devices under product code PAY between 2015 and 2026, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PAY

Recent clearances under product code PAY

Data sourced from openFDA. This site is unofficial and independent of the FDA.