Device Dossier
Diode Laser Machine - Hair-removal diode laser system
Device Dossier for Diode Laser Machine - Hair-removal diode laser system (Hair-removal diode laser system, Class IIb, sponsor Wiselink Group). ARTG…
- GMDN category: Hair-removal diode laser system
Intended purpose
The Diode Laser Machine (Model:BM-100) is intended for hair removal,permanent hair reduction on all skin types(Fitzpatrick skin type 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.