It is a different and less controlled category. The FDA says it has not authorized any microneedling medical device for over-the-counter sale (1). Its risk list for microneedling includes bleeding, bruising, redness, itching, peeling, dark or light spots and infection (1).
A review of 85 articles names active infection, darker skin and metal allergies as factors that raise the risk of side effects (6). A 2025 case report describes a serious skin injury after someone used an at-home device together with an oil (16). We explain how to compare home tools in the at-home kits guide.