Fixation, Vision Training, Binocular
The Fixation, Vision Training, Binocular device (product code NXR) is an ophthalmic device used to improve speed, accuracy, and coordination of binocular eye movements and changes of accommodation, indicated for treatment of conditions including convergence insufficiency, poor accommodation and vergence facility, and accommodative lag. It is classified as FDA Class 1, subject to general controls and exempt from 510(k) requirements, regulated under 21 CFR 886.1290 within the Ophthalmic specialty. The device carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- NXR
- Device Class
- FDA class 1
- Regulation Number
- 886.1290
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 4
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K051684 | EYEPORT VISION TRAINING SYSTEM | Mar 17, 2006 | Substantially Equivalent | Exercise Your Eyes, Inc. |
FEI Numbers
This FDA classification entry is associated with 13 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.