Lens, Prescription, Color Deficiency
Who Makes This Device Type in China?
Chinese manufacturers registered for this device type are concentrated in Fujian, Jiangsu and Shandong, and 1 other province: 5 hold an FDA registration. 1 is a contract manufacturer.
- Danyang Rimesis Optical Glasses Co., Ltd. Jiangsu, contract manufacturer
- Eyepol Optical Technology (Xiamen) Co., Ltd. Fujian
- Tsingtao Relly Optics Co., Ltd. Shandong, contract manufacturer
- Xiamen JS Polarizers Technology Co., Ltd. Fujian
- Zhejiang Sunny Optics Co., Ltd. Zhejiang, contract manufacturer
How Is NAI Classified?
Lens, Prescription, Color Deficiency is FDA product code NAI, Class 1, 21 CFR 886.5844.
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.
What Do the Recalls Say?
The FDA has recorded 1 recall under this product code since 2024. None was by a company in China. The root cause the FDA records most often is Device Design (1).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.
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