NXR — Fixation, Vision Training, Binocular Class I
FDA product code NXR covers "Fixation, Vision Training, Binocular", a Class I medical device regulated under 21 CFR 886.1290. Submissions are reviewed by the Ophthalmic panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- NXR
- Device Class
- Class I
- Regulation Number
- 886.1290
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K051684 | exercise your eyes | EYEPORT VISION TRAINING SYSTEM | March 17, 2006 |