Submission Details
| 510(k) Number | K251320 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
XTRA4
Sep 2025
Decision
135d
Days
—
Risk
About This 510(k) Submission
K251320 is an FDA 510(k) clearance for the XTRA4, a Media, Corneal Storage, submitted by Al.Chi.Mi.A. S.R.L (Ponte San Nicol?, 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 review panel.
Device Classification
| Product Code | LYX — Media, Corneal Storage |
| Device Class | — |
Manufacturer
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