Home / 510(k) Clearances / K211786

510(k) K211786

Independent Corneal Viewing Chamber (IVC-21) by Bausch + Lomb, Incorporated — Product Code LYX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 2021
Date Received
June 9, 2021
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 Bausch + Lomb, Incorporated

  • K230954 — Samfilcon B Custom Contact Lens (November 17, 2023)
  • K200528 — Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Sof (June 2, 2020)
  • K171404 — BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B) (July 17, 2017)

Other clearances for product code LYX

  • K251320 — XTRA4 (September 11, 2025)
  • K221759 — Cornisol (October 5, 2022)
  • 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)
  • K921729 — OPTISOL CORNEAL STORAGE MEDIA CONTAINER/MODIFIED (June 9, 1992)