Fixation, Vision Training, Binocular

What Is This Device?

To improve speed, accuracy, and coordination of binocular eye movements and changes of accommodation. To treat poor accommodation and vergence facility, convergence insufficiency, and accommodative lag.

What Is FDA Product Code NXR?

Fixation, Vision Training, Binocular is FDA product code NXR, Class 1, 21 CFR 886.1290.

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.