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510(k) K251320

XTRA4 by Al.Chi.Mi.A. S.R.L — Product Code LYX

K251320 is an FDA 510(k) premarket notification submitted by Al.Chi.Mi.A. S.R.L for the device "XTRA4". The FDA issued a decision of Substantially Equivalent on September 11, 2025. The device falls under product code LYX (Media, Corneal Storage), a Class U device. Al.Chi.Mi.A. S.R.L has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 2025
Date Received
April 29, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Corneal Storage
Device Class
Class U
Regulation Number
Review Panel
OP
Submission Type

Other clearances by Al.Chi.Mi.A. S.R.L

  • DEN200063 — Kerasave (May 2, 2022)
  • K162013 — Eusol-C (September 15, 2016)
  • K063617 — EUSOL-C (February 8, 2007)
  • K032422 — EUSOL-C (December 15, 2003)

Other clearances for product code LYX

  • K221759 — Cornisol (October 5, 2022)
  • K211786 — Independent Corneal Viewing Chamber (IVC-21) (December 3, 2021)
  • K162013 — Eusol-C (September 15, 2016)
  • K151061 — Cornea Cold (August 6, 2015)
  • K063304 — LIFE4C (December 21, 2007)
  • K063617 — EUSOL-C (February 8, 2007)
  • K032422 — EUSOL-C (December 15, 2003)
  • K954548 — THE CHEN MEDIUM (May 20, 1996)
  • K924165 — OPTISOL-GS CORNEAL STORAGE MEDIA (October 6, 1992)
  • K921729 — OPTISOL CORNEAL STORAGE MEDIA CONTAINER/MODIFIED (June 9, 1992)

FDA data resources