Product code NXR

Device name

Fixation, Vision Training, Binocular

Medical specialty

Ophthalmic

Device class

1

Regulation number

886.1290

Review panel

OP

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset