Desire Model U
Tripollar Desire Packed Rose Gold USA
7manufacturers in China registered for this device type
1catalogue number
5510(k) clearances naming this product code
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 | 2023-12-15 |
| 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 |
| Distribution end date | 2023-12-15 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Desire model U | Withdrawn |
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 |
| Stop VX Model U | Pollogen Ltd | 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 |
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.