K223074 is an FDA 510(k) clearance for the CorNeat EverPatch. This device is classified as a Prosthesis, Eyelid Spacer/graft, Polymer (Class II - Special Controls, product code QWU).
Submitted by Corneat Vision , Ltd. (Raanana, IL). The FDA issued a Cleared decision on June 2, 2023, 245 days after receiving the submission on September 30, 2022.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.3130. For Implantation To Reinforce And Aid In Reconstruction Of The Soft Tissues Of The Eyelid And Eyelid Area..
| 510(k) Number | K223074 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2022 |
| Decision Date | June 02, 2023 |
| Days to Decision | 245 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | QWU - Prosthesis, Eyelid Spacer/graft, Polymer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.3130 |
| Definition | For Implantation To Reinforce And Aid In Reconstruction Of The Soft Tissues Of The Eyelid And Eyelid Area. |