QPE
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Phototherapy Device For Reducing The Appearance Of Acute Post-Surgical Incisions
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4880
- Medical specialty
- General, Plastic Surgery
- FDA 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.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| Klox Biophotonic LumiHeal System (DEN200005) | Klox Technlogies, Inc. | 2021-12-03 |
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