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Pollogen, Ltd.

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.

At-home radiofrequency (RF) wrinkle devices (PAY, 5)

510(k) cleared

GENEO X ELITE

510(k) number
K242227
Applicant
Pollogen, Ltd.
Product code
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. FDA doesn't host a document for this record at the usual address.

510(k) cleared

Geneo X Elite

510(k) number
K233766
Applicant
Pollogen, Ltd.
Product code
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.

510(k) cleared

Pollogen STOP U Model UXV Device

510(k) number
K220322
Applicant
Pollogen, Ltd.
Product code
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.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.

510(k) cleared

STOP U Model UXV Device

510(k) number
K203665
Applicant
Pollogen, Ltd.
Product code
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. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.

510(k) cleared

STOP U (Packed Black USA), STOP U (Packed White USA)

510(k) number
K182774
Applicant
Pollogen, Ltd.
Product code
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.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.