FDA product code REG: Suntan Lamp
REG is the FDA product code for suntan lamp. It is a Class II device, regulated under 21 CFR 878.4635 and reviewed by the General and Plastic Surgery panel. Devices under REG reach the market by 510(k); FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for REG devices.
Definition
A lamp that produces ultraviolet radiation in the wavelength range of 200 to 400 nanometers in air and that is intended for use in any sunlamp product or fixture.
Classification
| Field | Value |
|---|---|
| Device name | Suntan Lamp |
| 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 REG devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2009-09-08.
Frequently asked questions
What is FDA product code REG?
REG is the FDA product code for suntan lamp. 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 REG?
Class II, regulation 21 CFR 878.4635. Typical premarket route: 510(k).
Have REG devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2009-09-08.
Next steps
- Run an FDA pathway report with predicate devices for product code REG
- Run a recall and safety report across every REG manufacturer
- Watch product code REG 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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