XTRA4— 510(k) K251320

Substantially Equivalent

Al.Chi.Mi.A. S.R.L

FDA 510(k) clearance K251320 for XTRA4, Substantially Equivalent on 2025-09-11. Applicant: Al.Chi.Mi.A. S.R.L. Device class: Unclassified.

Clearance details

Applicant: Al.Chi.Mi.A. S.R.L
Product code: Code LYX
Device class: Unclassified
Advisory panel: Unknown
Date received: 2025-04-29
Decision date: 2025-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ponte San Nicolò, IT

Download summary PDF View on FDA.gov ↗

Recent devices under product code LYX

K221759 — Cornisol2022-10-05
K211786 — Independent Corneal Viewing Chamber (IVC-21)2021-12-03
K162013 — Eusol-C2016-09-15
K151061 — Cornea Cold2015-08-06
K063304 — LIFE4C2007-12-21

More clearances from Al.Chi.Mi.A. S.R.L

DEN200063 — Kerasave2022-05-02

Data sourced from openFDA. This site is unofficial and independent of the FDA.