QPE — Phototherapy Device For Reducing The Appearance Of Acute Post-Surgical Incisions Class II
FDA product code QPE covers "Phototherapy Device For Reducing The Appearance Of Acute Post-Surgical Incisions", a Class II medical device regulated under 21 CFR 878.4880. Submissions are reviewed by the General, Plastic Surgery panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QPE
- Device Class
- Class II
- Regulation Number
- 878.4880
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN200005 | klox technlogies | Klox Biophotonic LumiHeal System | December 3, 2021 |