FDA product code QKL: Lipoaspirate Washing System For Aesthetic Body Contouring
QKL is the FDA product code for lipoaspirate washing system for aesthetic body contouring. It is a Class II device, regulated under 21 CFR 878.5040 and reviewed by the General and Plastic Surgery panel. Devices under QKL reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
Wash, filter, concentrate, and or fragment autologous adipose tissue aspirated via liposuction for aesthetic body contouring without further manipulation
Classification
| Field | Value |
|---|---|
| Device name | Lipoaspirate Washing System For Aesthetic Body Contouring |
| Device class | Class II |
| Regulation | 21 CFR 878.5040 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
Recalls for QKL devices
openFDA lists no recalls for product code QKL.
Frequently asked questions
What is FDA product code QKL?
QKL is the FDA product code for lipoaspirate washing system for aesthetic body contouring. It is a Class II device, regulated under 21 CFR 878.5040 and reviewed by the General and Plastic Surgery panel.
What device class is QKL?
Class II, regulation 21 CFR 878.5040. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QKL
- Run a recall and safety report across every QKL manufacturer
- Watch product code QKL 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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