Accessories to Examination Light

What Is This Device?

Accessories that attach to the light and assist in magnifying, clarifying, enhancing the image being viewed.

How Is PEQ Classified?

Accessories To Examination Light is FDA product code PEQ, Class 1, 21 CFR 880.6320.

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.