DEN200005 is an FDA 510(k) submission for the Klox Biophotonic LumiHeal System. This device is classified as a Phototherapy Device For Reducing The Appearance Of Acute Post-surgical Incisions (Class II - Special Controls, product code QPE).
Submitted by Klox Technlogies, Inc. (Laval, CA). The FDA issued a Not Cleared (DENG) decision on December 3, 2021.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4880. 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..
| 510(k) Number | DEN200005 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | February 04, 2020 |
| Decision Date | December 03, 2021 |
| Days to Decision | 668 days |
| Submission Type | Direct |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | - |
| Product Code | QPE - Phototherapy Device For Reducing The Appearance Of Acute Post-surgical Incisions |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4880 |
| 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. |