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510(k) K063617

EUSOL-C by Al.Chi.Mi.A — Product Code LYX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 2007
Date Received
December 5, 2006
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

  • K251320 — XTRA4 (September 11, 2025)
  • DEN200063 — Kerasave (May 2, 2022)
  • K162013 — Eusol-C (September 15, 2016)
  • 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)
  • K162013 — Eusol-C (September 15, 2016)
  • K151061 — Cornea Cold (August 6, 2015)
  • K063304 — LIFE4C (December 21, 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)