Device Dossier

Skin surface treatment system generator

Device Dossier for Skin surface treatment system generator (Skin surface treatment system generator, Class IIb, sponsor Cutera). ARTG record, intended…

Intended purpose

A device that is a combination of technologies such as a fluorescent light generator, pulsed UVB light generator, long-pulsed Nd:YAG laser, and Q-switched Nd:YAG laser, that as part of a skin surface treatment system is used for ablative and non-ablative treatment of the skin surface (e.g., removal of pigmented lesions, acne, psoriasis, wrinkles, tattoos, hair). The energies generated by this device are conducted through dedicated applicators applied by a practitioner or staff to a patients skin during treatment. Also for the temporary increase in clear nail in patients with onychomycosis (eg. dermatophytes Trichopyton Rubryum and T. mentagryphytes and/or yeasts Cadida albicans etc)

TGA Public Summary