Deka Truist
The DEKA TRUIST is a versatile medical platform that can be equipped with various types of laser and pulsed light handpieces. Thanks to its universal connector it is possible to quickly…
The DEKA TRUIST is a versatile medical platform that can be equipped with various types of laser and pulsed light handpieces. Thanks to its universal connector it is possible to quickly insert and deactivate the various handpieces to cover a wide spectrum of application. The available handpieces are: – VIVID: 808±10 nm Laser – SPARKS: 1064nm Laser – PRISMA: 1064nm Q-Switched laser – VIRIDIS: Pulsed Light handpiece 15mmx13mm with integrated 500-1200 nm filter – LILAC: Pulsed Light handpiece 48mmx13mm with interchangeable filters – RUBER: Pulsed Light handpiece 48mmx17mm with integrated 550nm filter – LAZUR: Pulsed Light handpiece 48mmx13mm with integrated 420-950 nm filter Emission activation is either by footswitch or fingerswitch. Electrical specifications are 115-240V~, 50-60Hz, 2300VA max.
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 | El.en. SPA |
|---|---|
| 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) | K192539 |
| Record published | 2023-04-27 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -10 to 50 °C; Storage environment humidity 10 to 90 % RH; Storage environment atmospheric pressure 70 to 106 KiloPascal; Handling environment temperature 10 to 30 °C; Handling environment humidity 30 to 75 % RH; Handling environment atmospheric pressure 70 to 106 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M117B1 | 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 |
| Silk’n | Home Skinovations, Ltd. | 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 |
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.