FDA product code QPE: Phototherapy Device For Reducing The Appearance Of Acute Post-Surgical Incisions
QPE is the FDA product code for phototherapy device for reducing the appearance of acute post-surgical incisions. It is a Class II device, regulated under 21 CFR 878.4880 and reviewed by the General and Plastic Surgery panel. Devices under QPE reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
This device consists of a light emitting device and a photoconverter gel and is intended to employ light energy for reducing the appearance of acute post-surgical incisions. This classification does not include products which contain drugs or biologics.
Classification
| Field | Value |
|---|---|
| Device name | Phototherapy Device For Reducing The Appearance Of Acute Post-Surgical Incisions |
| Device class | Class II |
| Regulation | 21 CFR 878.4880 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
Recalls for QPE devices
openFDA lists no recalls for product code QPE.
Frequently asked questions
What is FDA product code QPE?
QPE is the FDA product code for phototherapy device for reducing the appearance of acute post-surgical incisions. It is a Class II device, regulated under 21 CFR 878.4880 and reviewed by the General and Plastic Surgery panel.
What device class is QPE?
Class II, regulation 21 CFR 878.4880. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QPE
- Run a recall and safety report across every QPE manufacturer
- Watch product code QPE 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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