Product code ODK
- Device name
- Refractive Corneal Implant
- Medical specialty
- Unknown
- Device class
- f
- Review panel
- OP
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- 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.
- Source
- FDA openFDA device classification dataset