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 Jvaf). ARTG record,…

Intended purpose

The HS-900 is a platform treatment device which combines IPL/EPL(IPL+RF)/RF Bipolar/RF Monopolar/Q-switched Nd:YAG/Er:Glass/Er:YAG/1064nm Long pulsed Nd:YAG function. The device is designed with a mains electricity(AC-powered) mobile (on wheels) assembly of devices that uses multiple therapeutic modalities in combination or in isolation for ablative and non-ablative treatment of skin surface. System is intended to be used for dermatological applications such as for permanent hair removal in patients, reduction of pigmented lesions, reduction of vascular lesions, treat scars through coagulation and vaporization, and to break pigments like tattoo ink or treat pigmentation and pigmented lesions such as nevus of Ota, freckles, Melasma, skin resurfacing and skin rejuvenation.

TGA Public Summary