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,…
- GMDN category: Blue-light phototherapy lamp clinical
Intended purpose
A reusable, 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 acute and chronic wounds (including scarring), improve cosmesis and function. 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.