FDA product code OEL: Laser, Benign Prostatic Hyperplasia
OEL is the FDA product code for laser, benign prostatic hyperplasia. It is a Class II device, regulated under 21 CFR 878.4810 and reviewed by the General and Plastic Surgery panel. Devices under OEL reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
Laser ablation of prostatic tissue for the treatment of benign prostatic hyperplasia
Classification
| Field | Value |
|---|---|
| Device name | Laser, Benign Prostatic Hyperplasia |
| Device class | Class II |
| Regulation | 21 CFR 878.4810 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
Recalls for OEL devices
openFDA lists no recalls for product code OEL.
Frequently asked questions
What is FDA product code OEL?
OEL is the FDA product code for laser, benign prostatic hyperplasia. It is a Class II device, regulated under 21 CFR 878.4810 and reviewed by the General and Plastic Surgery panel.
What device class is OEL?
Class II, regulation 21 CFR 878.4810. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code OEL
- Run a recall and safety report across every OEL manufacturer
- Watch product code OEL 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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