Ruler, Nearpoint (Punctometer)

How Is HLE Classified?

Ruler, Nearpoint (Punctometer) is FDA product code HLE, Class 1, 21 CFR 886.1790.

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.