Stop VX Model U
STOP U Model UXV is a home use radiofrequency device for noninvasive treatment of mild to moderate facial wrinkles. It is intended for adult users with Fitzpatrick skin types II to IV and…
STOP U Model UXV is a home use radiofrequency device for noninvasive treatment of mild to moderate facial wrinkles. It is intended for adult users with Fitzpatrick skin types II to IV and is operated by the user.
Four electrodes deliver bipolar radiofrequency current into the skin. Electrical resistance converts this energy into heat in the dermal and subcutaneous layers. A temperature sensor near the electrodes monitors skin temperature and reduces or disables transmission when the maximum skin temperature is reached.
Device Components
The system comprises a handheld applicator, an external power supply and preparation gel. It operates at a nominal frequency of 1 MHz with a maximum output power of 5.7 watts.
Who Else Makes It
Concentrated in Guangdong (3), Fujian (2), Beijing (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xiamen Solex High-Tech Industries Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 9 |
| Shen Zhen HanShine Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Something High Electric (Xiamen) Company Inc. | Xiamen | Fujian | Contract manufacturer | 2 |
| Beijing Spiritlaser Science & Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 21 |
| Shenzhen Rainbow Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 12 |
| VIS (Shanghai) Technology Co., Ltd. | Jinshan District | Shanghai | Manufacturer | 10 |
| Shenzhen Lescolton Medical Equipment Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 7 |
Record
| Listed by | Pollogen Ltd, Israel |
|---|---|
| FDA product code | PAY |
| Device type | Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4420 |
| Establishment | Manufacturer |
| 510(k) | K203665 |
| Record published | 2021-06-30 |
| Record revised | 2025-06-30 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| STOP U MODEL UXV | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Newa Kit | Endymed Medical Ltd | 5 |
| Silk’n | Silkn Beauty Ltd. | 4 |
| Newa Plus Kit | Endymed Medical Ltd | 3 |
| Silk’n | Home Skinovations, Ltd. | 3 |
| Stop X | Pollogen Ltd | 2 |
| Sensilift | EL Global Trade Ltd. | 2 |
| FAQ 101 | Foreo Inc | 1 |
| Geneo, GLO2FACIAL, Elite | Pollogen Ltd | 1 |
| Stop VX2 Model U | Pollogen Ltd | 1 |
| Aura | Pollogen Ltd | 1 |
| Newa+, Kit, US, Pink | Endymed Medical Ltd | 1 |
| MyLift | Pollogen Ltd | 1 |
Showing 12 of 14. All products under Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K242227 | 2025-10-12 |
| K233766 | 2024-05-07 |
| K220322 | 2023-05-04 |
| K203665 | 2021-02-25 |
| K182774 | 2019-06-19 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.