FDA product code ODK: Refractive Corneal Implant
ODK is the FDA product code for refractive corneal implant. It is a HDE device, reviewed by the Ophthalmic panel. Devices under ODK reach the market by Unclassified; FDA lists no cleared 510(k)s for it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Refractive Corneal Implant |
| Device class | HDE |
| Review panel | OP — Ophthalmic |
| Medical specialty | Unknown |
| Premarket route | Unclassified |
| Implant | Yes |
Recalls for ODK devices
openFDA lists no recalls for product code ODK.
Frequently asked questions
What is FDA product code ODK?
ODK is the FDA product code for refractive corneal implant. It is a HDE device, reviewed by the Ophthalmic panel.
What device class is ODK?
HDE. Typical premarket route: Unclassified.
Next steps
- Run an FDA pathway report with predicate devices for product code ODK
- Run a recall and safety report across every ODK manufacturer
- Watch product code ODK for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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