Overview
- Federal officials cite numerous reports of severe burns, permanent scarring, subcutaneous fat loss, disfigurement and nerve damage, with some cases requiring surgery.
- Regulators caution that RF microneedling should never be done at home and advise treatment only by licensed, experienced providers.
- The FDA is evaluating RF microneedling devices, collaborating with manufacturers on risk reduction and inviting MedWatch reports from patients and clinicians.
- Many devices are cleared as Class II medical devices, and experts note that improper settings, poor technique or unregulated equipment can drive adverse outcomes.
- Dermatologists say the procedure can be safe and effective when properly performed with FDA‑cleared systems, and they urge thorough counseling on risks and alternatives.