Clearance Summary
myVision Track Model 005 received FDA 510(k) clearance under submission number K143211, sponsored by Vital Art and Science Incorporated. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2015-03-20.
- Submission: K143211
- Applicant / Sponsor: Vital Art and Science Incorporated
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1330
- Decision date: 2015-03-20
Classification & Regulation
This clearance is catalogued under FDA product code HOQ and 21 CFR 886.1330, within the Ophthalmic review panel as a Class I device.