Device Dossier

PRISMA - Intense pulsed light skin surface treatment system

Device Dossier for PRISMA - Intense pulsed light skin surface treatment system (Intense pulsed light skin surface treatment system, Class IIb, sponsor…

Intended purpose

The medical pulsed light is used for selective photothermolysis of endogenous and esogenous chromophores in dermatology and ophthalmology. PRISMA is a medical device indicated for the treatment of evaporative dry eye disease (meibomian gland dysfunction), treatment of melasma, treatment of acne vulgaris and hidradenitis suppurativa, treatment of hirsutism and pilonidal cyst, and photodynamic therapy. The pulsed light is used for skin resurfacing, hair removal and other skin treatments in aesthetic medicine. PRISMA is a device indicated for hair removal, skin rejuvenation, treatment of vascular lesions, and treatment of pigmented lesions.

TGA Public Summary