Newa+, Kit, US, Pink
The EndyMed Newa Plus is an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrinkles for adults woman with Fitzpatrick skin types I-IV.
7manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
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 | Endymed Medical 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) | DEN150005 |
| Record published | 2023-11-20 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | manufacturing date, serial number |
| Packaging | Carton of 6 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Plus, PINK | 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 |
| Stop VX Model U | Pollogen Ltd | 1 |
| Geneo, GLO2FACIAL, Elite | Pollogen Ltd | 1 |
| Stop VX2 Model U | Pollogen Ltd | 1 |
| Aura | Pollogen 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 |
|---|---|
| DEN150005 | 2015-12-18 |
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.