Device Dossier

Multi-modality skin surface treatment system

Device Dossier for Multi-modality skin surface treatment system (Multi-modality skin surface treatment system, Class IIa, sponsor Laseraid). ARTG record,…

Intended purpose

The Préime DermaFacial is a multi-modality skin care device with four technologies: AquaB cleanses and gently exfoliates the skin VibroX uses microdermabrasion to exfoliate and oxygenate the skin MicroT provides neuromuscular stimulation to superficial muscles to temporarily improve muscle tone UltraB transiently increases epidermal permeability through ultrasound-induced mechanical effects for transient enhancement of trans-epidermal penetration of topically applied agents. The device achieves its principle intended action by delivery of physical energy and mechanical abrasion; it does not act by pharmacological, immunological or metabolic means.

TGA Public Summary