Device Dossier

AvalancheLase - Dermatological Nd:YAG laser system

Device Dossier for AvalancheLase - Dermatological Nd:YAG laser system (Dermatological solid-state laser system, Class IIb, sponsor Qualtech Consulting…

Intended purpose

Nd:YAG Laser in Dermatology: • Treatment of mild to moderate inflammatory acne vulgaris • Verrucae and warts • Temporary increase of clear nail in patients with onychomycosis (e.g. dermatophytes, Trichophyton rubrum and T. mentagrophytes, and/or yeast Candida albicans, etc.) Aesthetic indications: 1. Alexandrite Laser: • Removal of unwanted hair, for stable long-term or permanent hair reduction and for treatment of PFB • Treatment of vascular and benign pigmented lesions 2. Nd:YAG Laser: • Removal of unwanted hair, for stable long-term or permanent hair reduction and for treatment of PFB. The laser is indicated for all skin types, Fitzpatrick I – VI, including tanned skin. • Skin rejuvenation, tightening, and non-ablative wrinkle reduction • Benign pigmented and vascular lesions

TGA Public Summary