ODK

Refractive Corneal Implant

Product code

ODK

Device name

Refractive Corneal Implant

Device class

Class F

Medical specialty

Unknown

Marketing pathway

HDE - Humanitarian Device Exemption

Flag

Implant

FDA classification definition

Intended for the reduction or elimination of myopia and astigmatism in patients with keratoconus so that their functional vision may be restored and the need for a corneal transplant procedure may be potentially deferred.

Definition text from the FDA device classification database (U.S. federal government work, public domain).