QPE · Phototherapy Device For Reducing The Appearance Of Acute Post-Surgical Incisions
General, Plastic Surgery · 21 CFR 878.4880 · Class 2
Overview
| Product Code | QPE |
|---|---|
| Device Name | Phototherapy Device For Reducing The Appearance Of Acute Post-Surgical Incisions |
| Regulation | 21 CFR 878.4880 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
Identification
The Klox Biophotonic LumiHeal System is a phototherapy device consisting of a blue light emitting Multi-LED Light device (KT-L Lamp) and a topical photoconverter gel (LumiHeal Gel). It is intended to provide blue light and fluorescent light energy for use on post-surgical incisions for scar management in Fitzpatrick Skin Type (FST) I-IV female patients 22 years and over.
Classification Rationale
Class II (special controls). The device is classified as Class II because general controls alone are insufficient to provide reasonable assurance of safety and effectiveness, and there is sufficient information to establish special controls to mitigate the risks to health.
Special Controls
In combination with the general controls of the FD&C Act. the phototherapy device for reducing the appearance of acute post-surgical incisions is subject to the following special controls:
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| DEN200005 | Klox Biophotonic LumiHeal System | Klox Technlogies, Inc. | Dec 3, 2021 | DENG |
Top Applicants
- Klox Technlogies, Inc. — 1 clearance
