Device Dossier
Dermatological solid-state laser system
Device Dossier for Dermatological solid-state laser system (Dermatological solid-state laser system, Class IIb, sponsor Ebos Medical Devices). ARTG…
- GMDN category: Dermatological solid-state laser system
- Sponsor: Ebos Medical Devices
Intended purpose
This device is intended for use in the professional healthcare facility environment requiring selective photothermolysis of target chromophores in desired tissue. The 755 nm wavelength is intended to be used by a trained physician for: reducing the papule of Pseudofolliculitis barbae (PFB) improving the Port-wine stain removing the Congenital Melanocytic Nevi (CMN) The 1064 nm wavelength is intended to be used by a trained physician for: reducing the papule of Pseudofolliculitis barbae (PFB) improving the Port-wine stain