K251320 is an FDA 510(k) clearance for the XTRA4. This device is classified as a Media, Corneal Storage.
Submitted by Al.Chi.Mi.A. S.R.L (Ponte San Nicolò, IT). The FDA issued a Cleared decision on September 11, 2025, 135 days after receiving the submission on April 29, 2025.
This device falls under the Ophthalmic FDA review panel.
| 510(k) Number | K251320 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 29, 2025 |
| Decision Date | September 11, 2025 |
| Days to Decision | 135 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | LYX - Media, Corneal Storage |
| Device Class | - |