Fixation, Vision Training, Binocular

NXR · Class I — Low Risk (general controls) · Ophthalmic · 21 CFR 886.1290

Classification

FDA Product Code: NXR
Device class: Class I — Low Risk (general controls)
Regulation: 21 CFR 886.1290
Review panel: OP
Medical specialty: Ophthalmic
Submission type: 4
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 13

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown