FDA product code PUN: Lice Removal Kit Containing A Solution
PUN is the FDA product code for lice removal kit containing a solution. It is a Class I device, regulated under 21 CFR 880.5960 and reviewed by the General Hospital panel. Devices under PUN reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
To remove lice eggs from hair
Classification
| Field | Value |
|---|---|
| Device name | Lice Removal Kit Containing A Solution |
| Device class | Class I |
| Regulation | 21 CFR 880.5960 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Recalls for PUN devices
openFDA lists no recalls for product code PUN.
Frequently asked questions
What is FDA product code PUN?
PUN is the FDA product code for lice removal kit containing a solution. It is a Class I device, regulated under 21 CFR 880.5960 and reviewed by the General Hospital panel.
What device class is PUN?
Class I, regulation 21 CFR 880.5960. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code PUN
- Run a recall and safety report across every PUN manufacturer
- Watch product code PUN 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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