WASHINGTON (dpa-AFX) - The U.S. Food and Drug Administration is currently raising awareness about reports of serious complications, such as burns, scarring, fat loss, disfigurement, and nerve damage, with the use of Radiofrequency or RF microneedling with specific uses of radiofrequency microneedling devices.
RF microneedling is used for dermatologic and aesthetic procedures, including the treatment of wrinkles, resurfacing, tightening, acne treatment, skin laxity, and rejuvenation. RF microneedling offers advantages over laser resurfacing and chemical peels, particularly in terms of safety, precision, and downtime, making it a preferred option for non-surgical aesthetics.
Radiofrequency microneedling is a medical procedure that combines two technologies, allowing radiofrequency energy to be delivered to specified target depths in the skin via needle electrodes, also known as microneedles, while measuring temperature and impedance within the tissue.
Radiofrequency creates an oscillating electrical current with a frequency of millions of cycles per second, causing vibrations and collisions between charged molecules, which results in the production of heat and changes in tissue. It is to be noted that radiofrequency energy transmission is highly dependent on the hydration of the skin, collagen, and electrolyte content, and many other variables.
When planning to use the RF microneedling procedure, the FDA recommends seeking care from a licensed health care provider with training and experience in the use of RF microneedling devices.
Additionally, the FDA advises customers to consult with their healthcare provider to discuss the benefits and risks of all available dermatologic and aesthetic skin procedures.
The FDA warns against using RF microneedling as a cosmetic treatment at home, as it is a medical procedure.
RF microneedling devices are classified as Class II medical devices, cleared by the FDA through the 510(k) process.
It is worth noting that the global market for RF Microneedling was estimated at $385.2 million in 2024 and is expected to reach $ 556.1 million by 2030.
Additionally, in conjunction with monitoring reports of adverse events and keeping the public informed, the FDA is collaborating with manufacturers of these devices to assess the issue and identify mitigation strategies as needed.
While the underlying demand for minimally invasive aesthetic treatments remains strong, the warning may slow uptake, particularly in applications involving thin tissues or high-risk zones. Healthcare providers and device manufacturers will likely place greater emphasis on safety credentials, robust clinical data, operator training, and risk mitigation measures.
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