K221759 is an FDA 510(k) clearance for the Cornisol. This device is classified as a Media, Corneal Storage.
Submitted by Aurolab (Veerapanjan, Madurai, IN). The FDA issued a Cleared decision on October 5, 2022, 110 days after receiving the submission on June 17, 2022.
This device falls under the Ophthalmic FDA review panel.
| 510(k) Number | K221759 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 17, 2022 |
| Decision Date | October 05, 2022 |
| Days to Decision | 110 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | LYX - Media, Corneal Storage |
| Device Class | - |