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510(k) K151061

Cornea Cold by Eurobio — Product Code LYX

K151061 is an FDA 510(k) premarket notification submitted by Eurobio for the device "Cornea Cold". The FDA issued a decision of Substantially Equivalent on August 6, 2015. The device falls under product code LYX (Media, Corneal Storage), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 2015
Date Received
April 20, 2015
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 for product code LYX

  • K251320 — XTRA4 (September 11, 2025)
  • K221759 — Cornisol (October 5, 2022)
  • K211786 — Independent Corneal Viewing Chamber (IVC-21) (December 3, 2021)
  • K162013 — Eusol-C (September 15, 2016)
  • 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