U.V. Light, Tlc
Which Manufacturers in China Make This?
Chinese manufacturers registered for this device type are based in Guangdong and Zhejiang: 3 hold an FDA registration.
- Aopu Lighting (Jinyun) Co., Ltd. Zhejiang, contract manufacturer
- Shenzhen Ctlite Technology Co., Ltd. Guangdong
- Sunplus LED Technology Co., Ltd. Guangdong
What Is FDA Product Code DJS?
U.V. Light, Tlc is FDA product code DJS, Class 1, 21 CFR 862.2270.
How Does It Reach the US Market?
It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States. It is also exempt from most of the quality system regulation.
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