Silk’n
6 catalogue numbers from Flash & Go Compact, listed by Home Skinovations, Ltd., Israel, under Powered Light Based Non-Laser Surgical Instrument With Thermal Effect. 31 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Guangdong (11), Beijing (10), Hebei (3). 5 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 |
| VTech Communications Ltd | Dongguan | Guangdong | Contract manufacturer | 5 |
| Beijing Starlight Science & Technology Development Co., Ltd. | Beijing | Beijing | Contract manufacturer | 4 |
| Guangzhou Telefield Limited | Guangzhou | Guangdong | Contract manufacturer | 3 |
| Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 17 |
| Beijing Winkonlaser Technology Limited | Beijing | Beijing | Contract manufacturer | 14 |
| Beijing Beautemax Technology Limited | Beijing | Beijing | Contract manufacturer | 13 |
| Guangdong Fuqiang Beauty Equipment Co., Limited | Qingyuan | Guangdong | Manufacturer | 13 |
| Shenzhen Perfect Idea Technology Limited | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Beijing Adss Development Co., Ltd. | Beijing | Beijing | Manufacturer | 8 |
| Rejuva Fresh LLC | Shenzhen | Guangdong | Manufacturer | 6 |
Showing 12 of 31. All 31 manufacturers in China registered for Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Record
| Listed by | Home Skinovations, Ltd., Israel |
|---|---|
| FDA product code | ONF |
| Device type | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4810 |
| 510(k) | K141242 |
| Record published | 2016-08-15 |
| 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 temperature -40 to 70 °C; Storage environment humidity 10 to 90 % RH; Storage environment atmospheric pressure 50 to 106 KiloPascal; Handling environment temperature 10 to 35 °C; Handling environment humidity 30 to 75 % RH; Handling environment atmospheric pressure 70 to 106 KiloPascal |
| Packaging | Box of 6, box of 4, box of 2 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Flash & Go Compact | In distribution | |
| BellaGlide | In distribution | |
| Flash & Go Express | In distribution | |
| Flash & Go Pro | In distribution | |
| Jewel | In distribution | |
| Glide | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Isolaz | Solta Medical, Inc. | 21 |
| Quantaforte | Quanta System Spa | 8 |
| Apolomed | Shanghai Apolo Medical Technology Co., Ltd. | 7 |
| Me | Iluminage Ltd | 7 |
| Remington | Spectrum Brands, Inc. | 6 |
| Huamei | Shandong Huamei Technology Co., Ltd. | 6 |
| Remington Products | Spectrum Brands, Inc. | 6 |
| Intense Pulsed Light (IPL) System | Shenzhen Fansizhe Science AND Technology Co., Ltd. | 5 |
| Iluminage | Iluminage Ltd | 5 |
| Luma Rx | Spectrum Brands, Inc. | 5 |
| Silk’n | Silkn Beauty Ltd. | 4 |
| TheraClear | Theravant Corporation | 4 |
Showing 12 of 133. All products under Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
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.