K251320
- 510(k) number
- K251320
- Device name
- XTRA4
- Applicant
- Al.Chi.Mi.A. S.R.L IT
- Product code
- LYX — Media, Corneal Storage
- Decision date
- 2025-09-11
- Date received
- 2025-04-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K251320.pdf
Official FDA record: K251320
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.