510(k) DEN200005
DEN200005 is an FDA 510(k) premarket notification submitted by Klox Technlogies, Inc. for the device "Klox Biophotonic LumiHeal System". The FDA issued a decision of De Novo Granted on December 3, 2021. The device falls under product code QPE (Phototherapy Device For Reducing The Appearance Of Acute Post-Surgical Incisions), a Class II device regulated under 21 CFR 878.4880.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- December 3, 2021
- Date Received
- February 4, 2020
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Phototherapy Device For Reducing The Appearance Of Acute Post-Surgical Incisions
- Device Class
- Class II
- Regulation Number
- 878.4880
- Review Panel
- SU
- Submission Type
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.