STOP U Model UXV Device
FDA 510(k)Class II (US FDA 510(k))
by Pollogen Ltd
Identifiers
- 510(k) Number
- K203665 FDA 510(k)
- FDA Product Code
- PAY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4420 FDA 510(k)
- Regulation Number
- 878.4420 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
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.
Frequently asked questions
Is the STOP U Model UXV Device designed for professional use in a clinic, or is it intended for home use by patients themselves?
The STOP U Model UXV Device is explicitly designed for home use by adult patients. It is classified as an Over-the-Counter Radiofrequency Coagulation Device for wrinkle reduction and does not require clinical supervision during treatment. The manufacturer’s instructions emphasize single-patient application, reinforcing its intended use outside professional settings.
How many electrodes does the STOP U Model UXV Device use, and what role do they play in the treatment process?
The STOP U Model UXV Device employs four electrodes to deliver bipolar radiofrequency (RF) energy. These electrodes target the dermis layer of the skin to treat mild to moderate facial wrinkles, while the device’s built-in temperature monitoring ensures safety during the procedure by controlling the energy application.
Does the STOP U Model UXV Device require sterilization between uses, or is it intended for reuse with the same patient?
The STOP U Model UXV Device is not intended for sterilization between uses. It is designed as a reusable electrosurgical instrument but is explicitly meant for single-patient application only, meaning it should not be shared across different individuals. The manufacturer’s instructions outline proper care and usage to maintain safety and efficacy.
What Fitzpatrick Skin Types does the STOP U Model UXV Device support for wrinkle reduction treatments?
The device is intended for adult users with Fitzpatrick Skin Types I-IV. This classification ensures compatibility with a broad range of skin tones while delivering controlled RF energy to the dermis for wrinkle reduction, as specified in the manufacturer’s product description.
What regulatory pathway was followed for FDA clearance of the STOP U Model UXV Device, and what classification does it hold?
The STOP U Model UXV Device received FDA 510(k) clearance under the classification K203665, with a decision code of SESE (Substantially Equivalent). It is classified as a Class II medical device under FDA regulation 878.4420, indicating it carries moderate risk and requires compliance with specific controls to ensure safety and effectiveness.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: RF Skin Device For Home Use | STOP X US Version - Pollogen, Pollogen STOP U Model UXV Device (K220322) - Innolitics, STOP U Model UXV Device (K203665) - FDA 510 (k), K220322 - Pollogen STOP U Model UXV Device - FDA 510 (k)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K203665 | Class II | Active |
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Manufacturer
- Manufacturer
- Pollogen Ltd
- FDA Applicant
- Pollogen, Ltd.
Sources (1)
- FDA 510(k) K203665 24 fields · synced Sep 19, 2026