Identifiers
- 510(k) Number
- K140255 FDA 510(k)
- FDA Product Code
- GEI FDA 510(k)
- Models / Variants
- Stop U (packed Black Usa) FDA 510(k)Stop U (packed White Usa) FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4400 FDA 510(k)
- Regulation Number
- 878.4400 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Stop U device is a non-invasive electrosurgical device that delivers RF energy to the skin, generating heat via electrical impedance in the dermis and subcutaneous layers. It is used for the non-invasive treatment of mild to moderate facial wrinkles and rhytides. The device includes an applicator unit, power supply, and preparation gel.
The Stop U device is supplied in two versions: Packed Black USA and Packed White USA. It is intended for use in adult users with Fitzpatrick Skin Types II-IV. The device has been cleared with the FDA 510K authorization, with the reference numbers K140255 and K182774.
Frequently asked questions
What is the Stop U device used for?
The Stop U device is used for the non-invasive treatment of mild to moderate facial wrinkles and rhytides in adult users with Fitzpatrick Skin Types II-IV.
How is the Stop U device supplied?
The Stop U device is supplied in two versions: Packed Black USA and Packed White USA, including an applicator unit, power supply, and preparation gel.
Is the Stop U device cleared for use?
Yes, the Stop U device has been cleared with the FDA 510K authorization, with reference numbers K140255 and K182774, indicating it is substantially equivalent to a predicate device.
What skin types is the Stop U device intended for?
The Stop U device is intended for use in adult users with Fitzpatrick Skin Types II-IV.
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: STOP U (Packed Black USA), STOP U (Packed White USA) (K182774) — FDA ..., Stop U (Packed Black Usa); Stop U (Packed White Usa) (K140255) — Fda ..., api.fda.gov, PDF Elissa Burg Regulatory Consultant BioVision Ltd Had Nes 183 Re: K182774 ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K140255 | Class II | Active |
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Manufacturer
- Manufacturer
- Pollogen Ltd
- FDA Applicant
- Pollogen, Ltd.
Sources (1)
- FDA 510(k) K140255 24 fields · synced Sep 22, 2026