Device Dossier

Blue-light phototherapy lamp, clinical

Device Dossier for Blue-light phototherapy lamp, clinical (Blue-light phototherapy lamp clinical, Class IIa, sponsor FB Dermatology). ARTG record,…

Intended purpose

A portable mains electricity (AC-powered) device designed to emit blue light (e.g., 400-470nm) for phototherapy applications, in conjunction with a photoconverter gel (not included), to treat skin diseases such as acne, rosacea, and psoriasis. The gel is applied to the skin to be treated, and illuminated by the blue-light lamp, where it is theorised that photon energy is created to produce the therapeutic effect. It is intended to be used by a healthcare professional in a clinical setting.

TGA Public Summary