Sponge, Eyelid Cleaning, Powered
Who Makes This Device Type in China?
2 manufacturers in China hold an FDA registration for this device type, based in Guangdong.
- Dongguan Yanxin Technology Co., Ltd. Guangdong
- Shenzhen Create Technology Co., Ltd. Guangdong
What Is This Device?
This device type is intended to cleanse the eyelid margins and eyelashes by a healthcare professional.
How Is PYU Classified?
Sponge, Eyelid Cleaning, Powered is FDA product code PYU, Class 1, 21 CFR 878.4820.
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.
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