FDA product code NXF: Gas, Laser Generating
NXF is the FDA product code for gas, laser generating. It is a Class I device, regulated under 21 CFR 878.4810 and reviewed by the General and Plastic Surgery panel. Devices under NXF reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
Special laser gas mixtures used as a lasing medium
Classification
| Field | Value |
|---|---|
| Device name | Gas, Laser Generating |
| Device class | Class I |
| Regulation | 21 CFR 878.4810 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Recalls for NXF devices
openFDA lists no recalls for product code NXF.
Frequently asked questions
What is FDA product code NXF?
NXF is the FDA product code for gas, laser generating. It is a Class I device, regulated under 21 CFR 878.4810 and reviewed by the General and Plastic Surgery panel.
What device class is NXF?
Class I, regulation 21 CFR 878.4810. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code NXF
- Run a recall and safety report across every NXF manufacturer
- Watch product code NXF 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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