Silk’n
An over the counter device intended for the removal of unwanted hair. Also intended for permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of…
An over the counter device intended for the removal of unwanted hair. Also intended for permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of treatment regime. The electric output is indicated for facial stimulation for over-the-counter aesthetic use.
Who Else Makes It
Concentrated in Guangdong (19), Shanghai (1), Fujian (1). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hong Qiangxing (Shen Zhen) Electronics Limited | Shenzhen | Guangdong | Contract manufacturer | 19 |
| Xiamen Solex High-Tech Industries Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 9 |
| Shenzhen Xiangzhida Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 7 |
| Guangdong Ace-Tec Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 6 |
| Shenzhen Zowee Smart Manufacturing Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Foshan Shiding Technology Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 4 |
| Rosti Integrated Manufacturing Solutions (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 2 |
| Shenzhen Kaiyan Medical Equipment Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 17 |
| Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 17 |
| Shenzhen Huayan E-Commerce Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Zhongshan Kingdom Electrical Appliance Co., Ltd. | Zhongshan | Guangdong | Manufacturer | 11 |
| VIS (Shanghai) Technology Co., Ltd. | Jinshan District | Shanghai | Manufacturer | 10 |
Showing 12 of 22. All 22 manufacturers in China registered for Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Record
| Listed by | Home Skinovations, Ltd., Israel |
|---|---|
| FDA product code | NFO |
| Device type | Stimulator, Transcutaneous Electrical, Aesthetic Purposes |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5890 |
| 510(k) | K171433 |
| Record published | 2018-01-25 |
| Record revised | 2023-06-12 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment atmospheric pressure 50 to 106 KiloPascal; Handling environment atmospheric pressure 70 to 106 KiloPascal; Storage environment humidity 10 to 90 % RH; Handling environment humidity 30 to 75 % RH; Storage environment temperature -40 to 70 °C; Handling environment temperature 10 to 35 °C |
| Packaging | Box of 6 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Infinity | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MicroCurrent Face-Lift Pen 6 in 1 | Geske Beauty Tech Gmbh | 13 |
| Ziip Beauty | Ziip Inc | 9 |
| NuFACE | Nuface | 9 |
| MicroCurrent Face-Lifter 6 in 1 | Geske Beauty Tech Gmbh | 5 |
| Jianchao Smart | Shenzhen Jianchao Intelligent Technology Co., Ltd. | 5 |
| Medi Lift | YA-MAN Ltd. | 5 |
| Jmoon | Shenzhen Ulike Smart Electronics Co., Ltd. | 5 |
| Nuon | Shenzhen Nuon Medical Equipment Co., Ltd. | 4 |
| Purelift | Xtreem Pulse | 4 |
| Johari Digital Healthcare Ltd. | Syrma Johari MedTech Limited | 4 |
| Bear 2 | Foreo Inc | 3 |
| Micro-current Facial Beauty Device | Shenzhen Aozemei Technology Co., Ltd. | 3 |
Showing 12 of 56. All products under Stimulator, Transcutaneous Electrical, Aesthetic Purposes
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.