# DEN200005: Klox Biophotonic LumiHeal System

- Pathway: De Novo (Direct)
- Applicant: Klox Technlogies, Inc.
- Decided: Dec 3, 2021 after 668 days
- Product code: QPE (Phototherapy Device For Reducing The Appearance Of Acute Post-Surgical Incisions)
- Device class: 2
- Regulation: 21 CFR 878.4880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The Klox Biophotonic LumiHeal™ System is indicated to provide blue light and fluorescent light energy for use on post-surgical incisions for scar management. The System is intended to be used in FST I-IV female patients 22 years and over.

Source page: https://510kreport.com/device/DEN200005
Methodology: https://510kreport.com/methodology