Shenzhen Siken 3D Technology and Development company successfully gets the FDA 510K approval for our SKB-1405 EMS facial device (Listing No. K163470) after 18 months efforts.
This means our device can be sold freely in the US market.
A FDA 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA.
Here is some amazing features of our SKB-1405 EMS facial Device:
- Exercise facial muscle under the skin
- Thighten up sagging skin
- Facial muscle toning
- Reduce extra fat, face slimming
- Face & neck lifting & remodeling
- Tighten loose skin on the underarms and legs
- A reduction in the appearance of double chins
- Non-Invasive, nonsurgical, painless
- Have a perfect body SPA at home
SKB-1405 facial device has received good comments from China, Japan, and Korea Markets.
With 510K approval, we have a big step to the US market.