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510(k) K921729

OPTISOL CORNEAL STORAGE MEDIA CONTAINER/MODIFIED by Chiron Intraoptics — Product Code LYX

K921729 is an FDA 510(k) premarket notification submitted by Chiron Intraoptics for the device "OPTISOL CORNEAL STORAGE MEDIA CONTAINER/MODIFIED". The FDA issued a decision of Substantially Equivalent on June 9, 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
June 9, 1992
Date Received
March 25, 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)
  • K924165 — OPTISOL-GS CORNEAL STORAGE MEDIA (October 6, 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)
  • K924165 — OPTISOL-GS CORNEAL STORAGE MEDIA (October 6, 1992)

FDA data resources