Clearance Summary
CorNeat EverPatch received FDA 510(k) clearance under submission number K223074, sponsored by Corneat Vision , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2023-06-02.
- Submission: K223074
- Applicant / Sponsor: Corneat Vision , Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.3130
- Decision date: 2023-06-02
Classification & Regulation
This clearance is catalogued under FDA product code QWU and 21 CFR 886.3130, within the Ophthalmic review panel as a Class II device.