Clearance Summary
EYEPORT VISION TRAINING SYSTEM received FDA 510(k) clearance under submission number K051684, sponsored by Exercise Your Eyes, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2006-03-17.
- Submission: K051684
- Applicant / Sponsor: Exercise Your Eyes, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1290
- Decision date: 2006-03-17
Classification & Regulation
This clearance is catalogued under FDA product code NXR and 21 CFR 886.1290, within the Ophthalmic review panel as a Class I device.