Device Dossier

Electronic cosmetic micro-needling handpiece

Device Dossier for Electronic cosmetic micro-needling handpiece (Electronic cosmetic micro-needling handpiece, Class IIa, sponsor Device Consulting).…

Intended purpose

For use by medical professionals for the treatment of moderate and severe wrinkles in the mid and lower face in adults aged 22 years and over with Fitzpatrick skin types I-IV. It is further indicated for fractional skin resurfacing including but not limited to areas such as the abdomen, arms, legs. Intended to be used in combination with a single use disposable sterile cartridge for the creation of high-density minute skin punctures to stimulate tissue regeneration and improve the appearance of the skin.

TGA Public Summary