Skip to contentDe Novo DEN200005
- Device
- Klox Biophotonic LumiHeal System
- Contact
- daniela jukic
- De Novo number
- DEN200005
- Product code
- QPE
- Regulation
- 878.4880
- Classification name
- phototherapy device for reducing the appearance of acute post-surgical incisions
- Decision
- granted (DENG)
- Decision date
- 2021-12-03
- Date received
- 2020-02-04
- Classification advisory
- General & Plastic Surgery
- Review advisory
- General & Plastic Surgery
- Type
- Direct
Current FDA Classification#
- Product code
- QPE
- Device name
- Phototherapy Device For Reducing The Appearance Of Acute Post-Surgical Incisions
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation
- 878.4880
- Implant
- N
- Life sustain/support
- N