Shenzhen Siken 3D Technology Development Co., Ltd.
ChinaFDA applicant, unverified FDA FEI 3007744197
- Devices
- 6
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Shenzhen Siken 3D Technology Development Co., Ltd. makes
The company manufactures at-home cosmetic and hair removal devices, including IPL (intense pulsed light) cooling hair removal systems, multi-functional facial beauty devices with features like galvanic stimulation and LED therapy, and LED light therapy masks for skin treatment.
These devices are classified as Class II under FDA regulations and are listed via 510(k) clearance. The company is based in the United States.
Catalogue
IPL Cooling Hair Removal Device Ref K222710
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Galvanic Spa, Model: SKB-1405 Ref K163470
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
IPL Cooling Hair Removal Device Ref K232845
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3007744197
- Address
- 6th Floor, Building E26, Tian'an Shenchuang Valley, Fenggang Town, Dongguan Guangdong
Frequently asked questions
How many devices does Shenzhen Siken 3D Technology Development Co., Ltd. have in the registry?
The registry currently lists 6 devices for Shenzhen Siken 3D Technology Development Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Shenzhen Siken 3D Technology Development Co., Ltd.'s devices?
Among its 6 most recently registered devices, Shenzhen Siken 3D Technology Development Co., Ltd. has devices listed in FDA 510(k) (6 devices).
What risk classes do Shenzhen Siken 3D Technology Development Co., Ltd.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Shenzhen Siken 3D Technology Development Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Shenzhen Siken 3D Technology Development Co., Ltd. in the registry?
The most recently registered devices listed for Shenzhen Siken 3D Technology Development Co., Ltd. include IPL Cooling Hair Removal Device, Multi-functional Facial Beauty Device ( SKB-1703, SKB-1803, SKB-1909, SKB-2003 SKB-2109, SKB-2129, SKB-2208PRO, SKB-2209), Galvanic Spa, Model: SKB-1405 and Multi-functional Facial Beauty Device (SKB-1703, SKB-1803, SKB-1809, SKB-1909, SKB-2109, SKB-2129, SKB-2208PRO, SKB-2209).