Device Dossier
Cosmetic phototherapy system, home-use
Device Dossier for Cosmetic phototherapy system, home-use (Cosmetic phototherapy system, home-use, Class IIa, sponsor Ergo Health Group). ARTG record,…
- GMDN category: Cosmetic phototherapy system, home-use
Intended purpose
Device is a non-invasive phototherapy device used on Face, neck and lower neckline region designed to emit LED light (wavelength range of 470nm to 1072nm) in the visible and invisible spectra for the cosmetic treatment of dermatological conditions in the home or in beauty salons. The LED device is intended for skin repair, skin rejuvenation, reduction of wrinkles, redness, pigmentation, scarring, sun damage, dullness, blemishes and inflammation.