NXR
- Product code
- NXR
- Device name
- Fixation, Vision Training, Binocular
- Device class
- Class 1
- 21 CFR
- 21 CFR 886.1290
- Medical specialty
- Ophthalmic
- Marketing pathway
- 510(K) Exempt
- 510(k) clearances (all years, FDA)
- 1 (all years; only the last 3 years are listed here)
FDA classification 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.
Official FDA classification page: NXR
Classification and pathway per current FDA publications. Data from openFDA (CC0).