Electronic cosmetic micro-needling handpiece

Intended purpose

A non-sterile, hand-held, battery powered device intended to be used in combination with a micro-needle cartridge (which contains micro-needles) to create high-density minute skin punctures to stimulate tissue regeneration to treat facial acne scars in adults aged 22 years or older and to help improve the cosmetic appearance of fine lines, wrinkles, stretch marks, surgical scars, enlarged pores and pigmentation conditions (dyschromia).