Tear Duct Occluder
Which Manufacturers in China Make This?
One manufacturer in China holds an FDA registration for this device type, based in Guangdong.
- Shenzhen Create Technology Co., Ltd. Guangdong
What Is This Device?
A nasolacrimal compression device is a device used to compress the nasolacrimal ducts to reduce drainage by means of temporary occlusion of the nasolacrimal system. The device may include a nose piece attached to a frame to apply pressure to the duct.
How Is PLX Classified?
Tear Duct Occluder is FDA product code PLX, Class 1, 21 CFR 886.5838.
What Does It Take to Sell It in the United States?
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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