Device Dossier

Multi-modality skin surface treatment system

Device Dossier for Multi-modality skin surface treatment system (Multi-modality skin surface treatment system, Class IIb, sponsor Syneron Candela…

Intended purpose

Combination laser systems intended for the treatment of dermatological conditions including acne, skin rejuvenation and wrinkles. It is also used in the treatment of surface veins of the face and body, vascular malformations, benign cutaneous lesions, benign cutaneous vascular lesions and benign pigmented lesions. The Picoway variant is also designed for tattoo removal. The Gentle variants for stable long term or permanent hair reduction and temporary increase of clear nail in patients with onychomycosis.

TGA Public Summary