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510(k) K924165

OPTISOL-GS CORNEAL STORAGE MEDIA by Chiron Intraoptics — Product Code LYX

K924165 is an FDA 510(k) premarket notification submitted by Chiron Intraoptics for the device "OPTISOL-GS CORNEAL STORAGE MEDIA". The FDA issued a decision of Substantially Equivalent on October 6, 1992. The device falls under product code LYX (Media, Corneal Storage), a Class U device. Chiron Intraoptics has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 1992
Date Received
August 19, 1992
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 by Chiron Intraoptics

  • K925631 — PHACOTRON GOLD MULTIFUNCTION ULTRASONIC HANDPIECE (July 29, 1993)
  • K921729 — OPTISOL CORNEAL STORAGE MEDIA CONTAINER/MODIFIED (June 9, 1992)
  • K921728 — DEXSOL CORNEAL STORAGE MEDIA CONTAINER, MODIFIED (June 9, 1992)

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)
  • K954548 — THE CHEN MEDIUM (May 20, 1996)
  • K921728 — DEXSOL CORNEAL STORAGE MEDIA CONTAINER, MODIFIED (June 9, 1992)

FDA data resources