Device Dossier

Skin surface treatment system applicator, light

Device Dossier for Skin surface treatment system applicator, light (Skin surface treatment system applicator, light, Class IIb, sponsor Professional…

Intended purpose

To be connected to and used part of a skin surface treatment system that generates a variety of light-based energies used for ablative and non-ablative treatment of skin conditions including; - The treatment of benign pigmented epidermal lesions including dyschromia, lentigines and ephelides (freckles) -The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations - The treatment of mild to moderate acne - The removal of unwanted hair when being carried out as part of the treatment for Polycystic Ovary Syndrome (PCOS), pilonidal sinus or pseudofolliculitis barbae

TGA Public Summary