Date Issued: October 15, 2025

The U.S. Food and Drug Administration (FDA) is making consumers, patients, and health care providers aware that serious complications have been reported with certain uses of radiofrequency (RF) microneedling devices.

These devices use an array of small electrodes, also known as microneedles, to deliver RF energy into and under the skin to produce local heating. With use of these devices for dermatologic or aesthetic procedures intended to improve the appearance of the skin (to treat wrinkles or to achieve skin effects, sometimes referred to as resurfacing, “tightening” or “rejuvenation”), the FDA is aware of reports of serious complications (adverse events) including burns, scarring, fat loss, disfigurement, and nerve damage, and the need for surgical repair or medical intervention to treat injuries.

While the FDA’s evaluation is ongoing, we are asking patients, caregivers, and health care providers to report any complications related to the use of these devices for dermatologic or aesthetic skin procedures to the FDA. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.

Recommendations for Patients and Caregivers

  • Be aware of reports of serious complications such as burns, scarring, fat loss, disfigurement, and nerve damage, with use of RF microneedling devices for dermatologic and aesthetic skin procedures.
  • Discuss the benefits and risks of all available dermatologic and aesthetic skin procedures with your health care provider.
  • If you are considering a skin procedure using RF microneedling, seek care from a licensed health care provider with training and experience on the use of RF microneedling devices, and ask your provider which devices they plan to use.
  • RF microneedling is a medical procedure, not a cosmetic treatment, and these devices should not be used at home.
  • If you experience any problems or are concerned after a skin procedure using RF microneedling, seek care from a licensed health care provider.
  • Report any problems or complications experienced from skin procedures with RF microneedling to the FDA. Your report, along with information from other sources, can provide information that helps improve patient safety.

Recommendations for Health Care Providers

  • Review and discuss the recommendations above with your patients and their caregivers.
  • Be aware of reports of serious complications with use of RF microneedling devices for dermatologic or aesthetic skin procedures, such as burns, scarring, fat loss, disfigurement, and nerve damage, which may require intervention.
  • Report any problems or complications experienced by patients from skin procedures with RF microneedling devices to the FDA.

Device Description

Radiofrequency (RF) energy is a type of electrical energy that creates heat in tissues. RF microneedling devices use an array of small electrodes (tiny, sharp needle-like projections also known as microneedles) to deliver this energy. During treatment, these microneedles penetrate the skin and allow the RF energy to reach specific depths within and under the skin. Each microneedle produces a small area of intense heat at its tip, which leads to changes of the tissue.

RF microneedling devices are Class II medical devices cleared by the FDA through the 510(k) process. You can search for FDA-cleared RF microneedling devices by the device name or manufacturer in the 510(k) database. This database also has summary documents that include the date the device received marketing authorization by the FDA, the indication for which the device was authorized by the FDA, and a summary of the information submitted to the FDA.

FDA Actions

The FDA is informing patients, caregivers, and health care providers about the potential risk of serious complications with RF microneedling devices used for dermatologic or aesthetic skin procedures. The FDA is working with manufacturers of these devices to evaluate the issue and identify mitigation strategies as appropriate.  

The FDA will continue to monitor reports of adverse events and keep the public informed if significant new information becomes available.

Reporting Problems with Your Device

If you think you had a problem with your device, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.

Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

Questions?

If you have questions, contact CDRH's Division of Industry and Consumer Education (DICE).