Device Dossier
Hair-removal diode laser system
Device Dossier for Hair-removal diode laser system (Hair-removal diode laser system, Class IIb, sponsor Import Health). ARTG record, intended purpose,…
- GMDN category: Hair-removal diode laser system
Intended purpose
Diode Laser Therapy Systems is intended to be used for hair removal of patients with hirsutism. It is indicated for use on all skin types (Fitzpatrick Skin Types I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.