510(k) K051684
K051684 is an FDA 510(k) premarket notification submitted by Exercise Your Eyes, Inc. for the device "EYEPORT VISION TRAINING SYSTEM". The FDA issued a decision of Substantially Equivalent on March 17, 2006. The device falls under product code NXR (Fixation, Vision Training, Binocular), a Class I device regulated under 21 CFR 886.1290.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 17, 2006
- Date Received
- June 23, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fixation, Vision Training, Binocular
- Device Class
- Class I
- Regulation Number
- 886.1290
- Review Panel
- OP
- Submission Type
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.