Sapiens. — 0.5mm Beard and Hair Dermaroller

The Sapiens. Growth Roller is a 540-titanium-needle micro-perforation device with 0.5 mm needles. Its depth exceeds the 0.3 mm threshold beyond which the ANSM considers a microneedling device to be a Class IIa Medical Device under EU Regulation MDR 2017/745. Before any sale, ParaDermia must obtain the EC Declaration of Conformity from Sapiens. and verify EUDAMED registration. In the absence of these documents, marketing incurs the reseller's liability. Mechanistically, the operating principle is documented: the micro-needles create temporary microchannels in the epidermis that increase skin permeability for small molecular weight topical active ingredients. The effect on local microcirculation is also documented. These mechanisms justify the combination of a dermaroller protocol + active serum – the order (roller first, then serum) is fundamental. The physiological or therapeutic claims used by the manufacturer (effects on collagen, on the cell cycle, “reactivation” of follicles) are non-compliant in the context of DGCCRF cosmetic regulations, and unusable without clinical device data if the MD status is retained. This document does not include them and sticks to factual mechanistic descriptions. Precautions to be systematically communicated in advice: exclusive individual use, rigorous disinfection before and after each use, maximum frequency of 2 times per week, skin recovery time between sessions, and formal contraindications on damaged, infected, or pathological skin. These precautions are not optional – they are conditions for safe use of an invasive device. The combination with the Beard Growth Serum is the primary target use. This two-piece kit is the differentiating product in the Sapiens. range and the lever for improving margin through the bundle effect.