Device Dossier
Skin surface treatment system generator
Device Dossier for Skin surface treatment system generator (Skin surface treatment system generator, Class IIb, sponsor Emergo). ARTG record, intended…
- GMDN category: Skin surface treatment system generator
Intended purpose
The intended purpose of the Neo Elite (Nd:YAG 1064nm) laser system is to treat dermatological medical conditions to reduce the visible effects of cutaneous or ungual symptoms of Acne, Rosacea, Onychomycosis and Psoriasis. Other intended purposes are the treatment of benign vascular lesions, hair removal, skin tightening, and benign pigmented lesions. The intended purpose of the Era Elite (Er:YAG 2940nm) laser systems is the ablation of benign cutaneous lesions and skin resurfacing. The devices are intended to be used by licensed Health Care Professionals or by trained personnel under the control and responsibility of licensed HCPs.