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FDA 510K approved for Siken 3D EMS Facial Device

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FDA 510K approved for Siken 3D EMS Facial Device

FDA 510K approved for Siken 3D EMS Facial Device

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.

Pub Time : 2017-07-05 17:48:31 >> News list
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Shenzhen  Siken 3D Technology Development Co., Ltd

Contact Person: Mr. Kimi

Tel: 86-755-86562985-819

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