510(k) K223074
K223074 is an FDA 510(k) premarket notification submitted by Corneat Vision , Ltd. for the device "CorNeat EverPatch". The FDA issued a decision of Substantially Equivalent on June 2, 2023. The device falls under product code QWU (Prosthesis, Eyelid Spacer/Graft, Polymer), a Class II device regulated under 21 CFR 886.3130.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 2, 2023
- Date Received
- September 30, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Eyelid Spacer/Graft, Polymer
- Device Class
- Class II
- Regulation Number
- 886.3130
- Review Panel
- OP
- Submission Type
For implantation to reinforce and aid in reconstruction of the soft tissues of the eyelid and eyelid area.