FDA product code OXW: Stimulator, Electrical, Transcutaneous, For Diabetic Retinopathy
OXW is the FDA product code for stimulator, electrical, transcutaneous, for diabetic retinopathy. It is a Not classified device, reviewed by the Ophthalmic panel. Devices under OXW reach the market by Contact FDA; FDA lists no cleared 510(k)s for it.
Definition
Electrical stimulation unit with leads and cutaneous electrodes used to apply an electrical current through the electrodes to the patient's eyelid to create a microcurrent loop that flows through the retina.
Classification
| Field | Value |
|---|---|
| Device name | Stimulator, Electrical, Transcutaneous, For Diabetic Retinopathy |
| Device class | Not classified |
| Review panel | OP — Ophthalmic |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
Recalls for OXW devices
openFDA lists no recalls for product code OXW.
Frequently asked questions
What is FDA product code OXW?
OXW is the FDA product code for stimulator, electrical, transcutaneous, for diabetic retinopathy. It is a Not classified device, reviewed by the Ophthalmic panel.
What device class is OXW?
Not classified. Typical premarket route: Contact FDA.
Next steps
- Run an FDA pathway report with predicate devices for product code OXW
- Run a recall and safety report across every OXW manufacturer
- Watch product code OXW 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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