Silk’n
The Silk'n Titan Allways is an over-the-counter home use device intended for non-invasive treatment of mild to moderate periorbital wrinkles for adult women who have Fitzpatrick skin types…
The Silk’n Titan Allways is an over-the-counter home use device intended for non-invasive treatment of mild to moderate periorbital wrinkles for adult women who have Fitzpatrick skin types I-IV. The Silk’n Titan Allways is designed as a hand-held device, battery operated which utilizes both Bi-Polar RF and low power light energies. The device includes RF generator, LEDs at wavelengths of 630±20nm and 850±20nm (Red and IR wavelengths, respectively) and a temperature stabilizer. The Silk’n Titan AllWays device consists of an applicator and an adaptor. The applicator is a handheld unit used for treatment. The device has a treatment surface with 3 electrodes and a control button with 4 surrounding indicator lights. The device has a rechargeable battery for cordless use, as well as an adapter for connection to the mains.
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 | Home Skinovations, 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 |
| 510(k) | K162784 |
| Record published | 2021-08-02 |
| Record revised | 2023-06-12 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -40 to 70 °C; Storage environment humidity 10 to 90 % RH; Handling environment atmospheric pressure 70 to 106 KiloPascal; Storage environment atmospheric pressure 50 to 106 KiloPascal; Handling environment temperature 10 to 35 °C; Handling environment humidity 30 to 75 % RH |
| Packaging | Box of 6 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Titan AllWays | In distribution | |
| BellaVisage Hybrid | In distribution | |
| Titan | 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 |
| 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 |
| MyLift | Pollogen Ltd | 1 |
Showing 12 of 14. All products under Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction
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.