QPE · Class II · 21 CFR 878.4880

FDA Product Code QPE: Phototherapy Device For Reducing The Appearance Of Acute Post-surgical Incisions

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.

Leading manufacturers include Klox Technlogies, Inc..

1
Total
0
Cleared
668d
Avg days
2021
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Phototherapy Device For Reducing The Appearance Of Acute Post-surgical Incisions Devices (Product Code QPE)

1 devices
1–1 of 1
Not Cleared Dec 03, 2021
Klox Biophotonic LumiHeal System
DEN200005
Klox Technlogies, Inc.
General & Plastic Surgery · 668d

About Product Code QPE - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code QPE since 2021, with 0 receiving FDA clearance (average review time: 668 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.

QPE devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →