Clearance Summary
EYESOPEN TONOMETER received FDA 510(k) clearance under submission number K032769, sponsored by Eye-Deas, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2003-09-23.
- Submission: K032769
- Applicant / Sponsor: Eye-Deas, LLC
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1930
- Decision date: 2003-09-23
Classification & Regulation
This clearance is catalogued under FDA product code HKY and 21 CFR 886.1930, within the Ophthalmic review panel as a Class II device.