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STOP U Model UXV Device

by Pollogen Ltd

510(k) K203665

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK203665 Date25 Feb 2021ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
PAY
FDA applicant
Pollogen, Ltd.
Device class
Class II
Regulation
21 CFR Part 878.4420
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The STOP U Model UXV Device is an Over-the-Counter Radiofrequency Coagulation Device for Wrinkle Reduction, classified under FDA regulation 878.4420. It delivers bipolar radiofrequency (RF) energy to the dermis layer of the skin to target mild to moderate facial wrinkles in adult users with Fitzpatrick Skin Types I-IV. The device employs four electrodes to apply controlled RF energy while monitoring skin temperature to ensure safety during treatment.

This device is intended for home use and is supplied as a reusable electrosurgical instrument. It requires no sterilisation between uses and is designed for single-patient application. The STOP U Model UXV Device is authorised under FDA 510(k) clearance (K203665) and is classified as a Class II medical device. Storage conditions and additional regulatory details are specified in the manufacturer’s instructions.

Devices cleared under K203665

3 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K203665
UDI-DISize and differences
Desire model U
POLLOGEN LTD
34670000RG-US / Desire model U07290016586459 —No longer on the market
STOP VX GOLD MODEL U STOP U MODEL UXV
POLLOGEN LTD
34650000GL-US / STOP U MODEL UXV07290016586466 —On the market
STOP VX MODEL U STOP U MODEL UXV
POLLOGEN LTD
34650000BP-US / STOP U MODEL UXV07290016586442 —On the market

Similar devices

Other devices filed under FDA product code PAY (Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction).

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