FDA product code SGQ: Intraoral Phototherapy Device
SGQ is the FDA product code for intraoral phototherapy device. It is a Class II device, regulated under 21 CFR 872.5595 and reviewed by the Dental panel. Devices under SGQ reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
An intraoral phototherapy device is an intraoral, non-ionizing, light-based device that is intended for non-surgical treatment of oral conditions such as oral mucositis.
Classification
| Field | Value |
|---|---|
| Device name | Intraoral Phototherapy Device |
| Device class | Class II |
| Regulation | 21 CFR 872.5595 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
Recalls for SGQ devices
openFDA lists no recalls for product code SGQ.
Frequently asked questions
What is FDA product code SGQ?
SGQ is the FDA product code for intraoral phototherapy device. It is a Class II device, regulated under 21 CFR 872.5595 and reviewed by the Dental panel.
What device class is SGQ?
Class II, regulation 21 CFR 872.5595. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code SGQ
- Run a recall and safety report across every SGQ manufacturer
- Watch product code SGQ 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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