FDA product code REF: Suntan Bed
REF is the FDA product code for suntan bed. It is a Class II device, regulated under 21 CFR 878.4635 and reviewed by the General and Plastic Surgery panel. Devices under REF reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
A bed or other platform that is designed to incorporate one or more ultraviolet lamps and intended for irradiation of any part of the human body, by ultraviolet radiation with wavelengths in air between 200 and 400 nanometers, to induce skin tanning.
Classification
| Field | Value |
|---|---|
| Device name | Suntan Bed |
| Device class | Class II |
| Regulation | 21 CFR 878.4635 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for REF devices
openFDA lists no recalls for product code REF.
Frequently asked questions
What is FDA product code REF?
REF is the FDA product code for suntan bed. It is a Class II device, regulated under 21 CFR 878.4635 and reviewed by the General and Plastic Surgery panel.
What device class is REF?
Class II, regulation 21 CFR 878.4635. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code REF
- Run a recall and safety report across every REF manufacturer
- Watch product code REF 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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