510(k) DEN200005
- Device
- Klox Biophotonic LumiHeal System
- Applicant
- Klox Technlogies, Inc.
- 510(k) number
- DEN200005
- Product code
- QPE
- Decision
- Unknown (DENG)
- Decision date
- 2021-12-03
- Date received
- 2020-02-04
- Regulation
- 878.4880
- Classification name
- Phototherapy Device For Reducing The Appearance Of Acute Post-Surgical Incisions
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Daniela Jukic
- Address
- 275, Boul. Armand Frappier Laval CA H7V 4A7 H7V 4A7
Source Documents#
510(k) summary PDF not indicated by FDA