NXR

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Fixation, Vision Training, Binocular

Device class

Class I (low risk)

Regulation

21 CFR 886.1290

Medical specialty

Ophthalmic

FDA definition

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.

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