Home / 510(k) Clearances / K954548

510(k) K954548

THE CHEN MEDIUM by Chen Ophthalmic Laboratories — Product Code LYX

K954548 is an FDA 510(k) premarket notification submitted by Chen Ophthalmic Laboratories for the device "THE CHEN MEDIUM". The FDA issued a decision of Substantially Equivalent on May 20, 1996. The device falls under product code LYX (Media, Corneal Storage), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 1996
Date Received
October 2, 1995
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)
  • K151061 — Cornea Cold (August 6, 2015)
  • K063304 — LIFE4C (December 21, 2007)
  • K063617 — EUSOL-C (February 8, 2007)
  • K032422 — EUSOL-C (December 15, 2003)
  • K924165 — OPTISOL-GS CORNEAL STORAGE MEDIA (October 6, 1992)
  • K921729 — OPTISOL CORNEAL STORAGE MEDIA CONTAINER/MODIFIED (June 9, 1992)

FDA data resources