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,…

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.

TGA Public Summary