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510(k) K162013

Eusol-C by Al.Chi.Mi.A. S.R.L — Product Code LYX

K162013 is an FDA 510(k) premarket notification submitted by Al.Chi.Mi.A. S.R.L for the device "Eusol-C". The FDA issued a decision of Substantially Equivalent on September 15, 2016. 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 15, 2016
Date Received
July 21, 2016
Clearance Type
Special
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

  • K251320 — XTRA4 (September 11, 2025)
  • DEN200063 — Kerasave (May 2, 2022)
  • K063617 — EUSOL-C (February 8, 2007)
  • K032422 — EUSOL-C (December 15, 2003)

Other clearances for product code LYX

  • K251320 — XTRA4 (September 11, 2025)
  • K221759 — Cornisol (October 5, 2022)
  • K211786 — Independent Corneal Viewing Chamber (IVC-21) (December 3, 2021)
  • 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)
  • K921728 — DEXSOL CORNEAL STORAGE MEDIA CONTAINER, MODIFIED (June 9, 1992)

FDA data resources