Device Dossier
Cosmetic phototherapy system, home-use
Device Dossier for Cosmetic phototherapy system, home-use (Cosmetic phototherapy system, home-use, Class IIa, sponsor Balco Brands). ARTG record,…
- GMDN category: Cosmetic phototherapy system, home-use
- Sponsor: Balco Brands
Intended purpose
The LED Light Therapy Mask (Model:EL00003) is an over the counter device intended to emit energy in the red and blue region of the light spectrum, specifically indicated to treat mild to moderate acne vulgaris of the face. The LED Light Therapy Mask (Model:EL00003) is an over the counter device intended to emit energy in the red and Near Infra-red spectrum and is intended for the use in the treatment of full-face wrinkles.