ODK — Refractive Corneal Implant Class f
FDA product code ODK covers "Refractive Corneal Implant", a Class f medical device. Submissions are reviewed by the Unknown panel. Devices under this code are implants.
Classification Details
- Product Code
- ODK
- Device Class
- Class f
- Regulation Number
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Unknown
- Implant
- Yes
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.