Lens, Fundus, Hruby, Diagnostic

What Is FDA Product Code HJI?

Lens, Fundus, Hruby, Diagnostic is FDA product code HJI, Class 1, 21 CFR 886.1395.

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. It is also exempt from most of the quality system regulation.

What Has Gone Wrong With It?

The FDA has recorded 1 recall under this product code since 2015. None was by a company in China. A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.