FDA product code NYX: Stimulator, Electrical, Transcutaneous, With Limited Output, For Aesthetic Purposes
NYX is the FDA product code for stimulator, electrical, transcutaneous, with limited output, for aesthetic purposes. It is a Class II device, regulated under 21 CFR 882.5890 and reviewed by the Neurology panel. Devices under NYX reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
Electrical stimulation for aesthetic purposes
Classification
| Field | Value |
|---|---|
| Device name | Stimulator, Electrical, Transcutaneous, With Limited Output, For Aesthetic Purposes |
| Device class | Class II |
| Regulation | 21 CFR 882.5890 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for NYX devices
openFDA lists no recalls for product code NYX.
Frequently asked questions
What is FDA product code NYX?
NYX is the FDA product code for stimulator, electrical, transcutaneous, with limited output, for aesthetic purposes. It is a Class II device, regulated under 21 CFR 882.5890 and reviewed by the Neurology panel.
What device class is NYX?
Class II, regulation 21 CFR 882.5890. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code NYX
- Run a recall and safety report across every NYX manufacturer
- Watch product code NYX 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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