Lens, Condensing, Diagnostic

How Is HJL Classified?

Lens, Condensing, Diagnostic is FDA product code HJL, Class 1, 21 CFR 886.1380.

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.

What Do the Recalls Say?

The FDA has recorded 1 recall under this product code since 2012. None was by a company in China. The root cause the FDA records most often is Employee error (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.