Device Dossier

Etherea - Multi-modality skin surface treatment system

Device Dossier for Etherea - Multi-modality skin surface treatment system (Multi-modality skin surface treatment system, Class IIb, sponsor Ebos Medical…

Intended purpose

An assembly of devices that generates various types of light energy for delivery via dedicated applicators for ablative and non-ablative treatment of the skin surface and mucosal surfaces such as the removal of pigmented lesions, resurfacing, acne, wrinkles, rejuvenation, tattoos and hair reduction. The laser system and its accessories are not intended for gynaecological procedures including but not limited to the treatment of diminished sensation during intercourse, dryness, loss of lubrication and pain during intercourse, vaginal pain or discomfort, vaginal laxity (looseness), urinary incontinence and urgency.

TGA Public Summary