FDA product code NXR: Fixation, Vision Training, Binocular
NXR is the FDA product code for fixation, vision training, binocular. It is a Class I device, regulated under 21 CFR 886.1290 and reviewed by the Ophthalmic panel. FDA has cleared 1 510(k) submission under NXR. The average 510(k) review took 267 days (median 267).
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.
Classification
| Field | Value |
|---|---|
| Device name | Fixation, Vision Training, Binocular |
| Device class | Class I |
| Regulation | 21 CFR 886.1290 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every NXR clearance
Top NXR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Exercise Your Eyes, Inc. | 1 | 2006-03-17 |
Most recent NXR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K051684 | Exercise Your Eyes, Inc. | EYEPORT VISION TRAINING SYSTEM | 2006-03-17 | 267 |
Recalls for NXR devices
openFDA lists no recalls for product code NXR.
Frequently asked questions
What is FDA product code NXR?
NXR is the FDA product code for fixation, vision training, binocular. It is a Class I device, regulated under 21 CFR 886.1290 and reviewed by the Ophthalmic panel.
What device class is NXR?
Class I, regulation 21 CFR 886.1290. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code NXR?
Across 1 cleared submissions the average was 267 days from receipt to decision (median 267).
Which companies have the most NXR clearances?
Exercise Your Eyes, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NXR
- Run a recall and safety report across every NXR manufacturer
- Watch product code NXR for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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