Home / 510(k) Clearances / K844249

510(k) K844249

K-SOL by Cilco, Inc. — Product Code LYX

K844249 is an FDA 510(k) premarket notification submitted by Cilco, Inc. for the device "K-SOL". The FDA issued a decision of Substantially Equivalent on April 30, 1985. The device falls under product code LYX (Media, Corneal Storage), a Class U device. Cilco, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 1985
Date Received
November 2, 1984
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 Cilco, Inc.

  • K861334 — CILCO DIAMOND KNIVES & DIAMOND KNIFE LINEAR GAUGE (May 2, 1986)
  • K854969 — CILCO SONOMETRICS A&B DIGITAL SYSTEM (DIGISCAN) (February 27, 1986)
  • K843319 — CILCO I/A SURGICAL PACK (February 14, 1985)
  • K843992 — CILCOR OPHTHALMIC INSTRUMENTS (November 21, 1984)
  • K843447 — CILCO DIAMOND KNIFE (October 5, 1984)
  • K841099 — OCTOPUS 500/500E (June 19, 1984)
  • K840475 — CYSTOTOME, 140-S (April 5, 1984)
  • K832405 — OPTHALMIC ENDOSCOPE (November 21, 1983)
  • K827371 — CILCO ASCAN (July 9, 1982)
  • K820933 — CILCO I/A HANDPIECE (June 14, 1982)

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