FDA

FDA warns of serious risks linked to radiofrequency microneedling procedures

October 15, 2025

FDA issued a safety communication regarding radiofrequency (RF) microneedling devices, which are used in dermatologic and aesthetic procedures to improve skin appearance. These devices deliver RF energy via microneedles to induce localized heating within the skin. While cleared as Class II medical devices through the 510(k) process, recent reports have highlighted serious complications including burns, scarring, fat loss, disfigurement, nerve damage, and the need for surgical or medical intervention.

Clinicians are advised to discuss risks and benefits with patients, ensure proper device selection and operator training, and report adverse events to FDA. The agency is actively working with manufacturers to assess the issue and develop mitigation strategies. RF microneedling should be treated as a medical procedure, not a cosmetic treatment, and shouldn't be performed outside of licensed clinical settings.

Source:

(2025, October 15). FDA. Potential Risks with Certain Uses of Radiofrequency (RF) Microneedling – FDA Safety Communication. https://www.fda.gov/medical-devices/safety-communications/potential-risks-certain-uses-radiofrequency-rf-microneedling-fda-safety-communication