The US Food and Drug Administration (FDA) [recently] finalized guidance explaining when it considers microneedling devices to be medical devices subject to premarket notification (510(k)) requirements.
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The final guidance, which comes more than three years after being released in draft form, has been revised to reflect the classification of microneedling devices for aesthetic use as Class II devices in response to aย De Novoย classification requestย for Bellus Medicalโs SkinPen. Since issuing theย classification order, FDA has cleared several other microneedling devices includingย Esthetic Educationโs Skinstylus Sterilock Microsystemย andย Refine USAโs Rejuvapen NXT.ย