Main Line Center for Laser Surgery

FDA Issues Safety Alert on Radiofrequency Microneedling Devices Following Reports of Severe Complications

- The FDA has issued a safety communication warning healthcare providers about serious complications from radiofrequency microneedling devices, including thermal burns, scarring, fat loss, and nerve damage. - These Class II medical devices, designed for skin rejuvenation and wrinkle reduction, have been associated with adverse events requiring surgical intervention or additional medical treatment. - The agency emphasizes that RF microneedling is a medical procedure requiring trained healthcare professionals, not a cosmetic treatment for home use. - Healthcare providers are advised to carefully assess treatment parameters, educate patients about risks, and report adverse events through the FDA's MedWatch system.