FDA product code RAB: Sunlamp Products (Pre-Standard)
RAB is the FDA product code for sunlamp products (pre-standard). It is a Class II device, regulated under 21 CFR 878.4635 and reviewed by the General and Plastic Surgery panel. Devices under RAB reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
A sunlamp product assembled or manufactured before november 9, 1979. These are Class II medical devices as of 2014.
Classification
| Field | Value |
|---|---|
| Device name | Sunlamp Products (Pre-Standard) |
| 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) |
| GMP exempt | Yes |
| Third-party 510(k) review eligible | Yes |
Recalls for RAB devices
openFDA lists no recalls for product code RAB.
Frequently asked questions
What is FDA product code RAB?
RAB is the FDA product code for sunlamp products (pre-standard). 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 RAB?
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 RAB
- Run a recall and safety report across every RAB manufacturer
- Watch product code RAB 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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