bfe8c597-d9f7-403a-aa26-d8c4f5900c65UpdatePublished82026-05-252018-10-23In Commercial DistributionEMTDAD61USMP0PrimaryHIBCCExceedAD61USMPAD61USMP329216357MT.DERM GmbH1The Exceed microneedling device is intended to create many, very tiny, microscopic punctures in the epidermal and dermal layers of the skin using sterile stainless steel needles. Exceed consists of - Control Unit - Handpiece with handpiece cable - Handpiece Holder - Power Supply - Instructions for UsefalsefalsefalsefalsefalsefalsefalsetruetruefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse61216Cosmetic micro-needling electronic handpiece, professionalA hand-held, electrically-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 and improve the appearance of the skin as part of collagen induction therapy (CIT). It includes controls to allow for treatment adjustments (e.g., puncture depth, frequency); a disposable micro-needle cartridge may be included. It is intended for clinical use by a healthcare provider to treat stretch marks, acne scarring, hyperpigmentation, wrinkles, and/or hair loss; it is not intended for energy-based skin treatment. This is a reusable device.falseActiveQAIPowered Microneedle DeviceStorage Environment TemperatureStorage Environment HumidityStorage Environment Atmospheric PressureHandling Environment TemperatureHandling Environment HumidityHandling Environment Atmospheric Pressurefalsefalse