5 FDA records filed under this company name, from 2019 to 2025, in rf for wrinkles (PAY, 5).
The applicant is the company that filed with FDA. It can be the brand you know or a manufacturer that makes devices sold under other brand names; the device name as filed often shows which. We don't merge different company names, so check the A–Z list for related entries.
PAY: Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction
Regulation
21 CFR 878.4420, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use
Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 4.
PAY: Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction
Regulation
21 CFR 878.4420, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use, as filed
“The STOP U Model UXV device is intended for use in the non-invasive treatment of mild to moderate facial wrinkles for adult users who have Fitzpatrick Skin Types I-IV.”
PAY: Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction
Regulation
21 CFR 878.4420, Class II
FDA decision
Substantially Equivalent (SESE)
Received
Indications for use, as filed
“The STOP U device is intended for use in the non-invasive treatment of mild to moderate facial wrinkles for adult users who have Fitzpatrick Skin Types II-IV.”