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510(k) K221759

Cornisol by Aurolab — Product Code LYX

K221759 is an FDA 510(k) premarket notification submitted by Aurolab for the device "Cornisol". The FDA issued a decision of Substantially Equivalent on October 5, 2022. The device falls under product code LYX (Media, Corneal Storage), a Class U device. Aurolab has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 2022
Date Received
June 17, 2022
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 Aurolab

  • K140039 — POLYCRYL (September 15, 2014)
  • K024091 — SILK SUTURES (February 28, 2003)
  • K024090 — NYLON SUTURE (February 28, 2003)

Other clearances for product code LYX

  • K251320 — XTRA4 (September 11, 2025)
  • 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)
  • K921728 — DEXSOL CORNEAL STORAGE MEDIA CONTAINER, MODIFIED (June 9, 1992)

FDA data resources