Ultrasound, Skin Permeation
Which Manufacturers in China Make This?
Chinese manufacturers registered for this device type are based in Guangdong: 2 hold an FDA registration.
- Guangdong Fuqiang Beauty Equipment Co., Limited Guangdong
- Shenzhen Rainbow Technology Co., Ltd. Guangdong
What Is This Device?
Indicated for the temporary disruption of the outer layer of skin for the application of drugs, etc.
How Is NRJ Classified?
Ultrasound, Skin Permeation is FDA product code NRJ, Class 2, 21 CFR 878.4410.
How Does It Reach the US Market?
A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. The review can be done by an FDA-accredited third party, which is usually faster. No clearance under this code names a Chinese applicant.
A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.
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