Device Dossier

Dermatological carbon dioxide laser system

Device Dossier for Dermatological carbon dioxide laser system (Dermatological carbon dioxide laser system, Class IIb, sponsor Alma Lasers). ARTG record,…

Intended purpose

Intended to incise, excise, ablate, coagulate and vaporize for dermatological and soft tissue applications. The laser system and its accessories are not intended for gynaecological procedures including but not limited to the treatment of Genitourinary Syndrome of Menopause (GSM), Vulvovaginal Atrophy (VVA) and Stress Urinary Incontinence (SUI).

TGA Public Summary