Microneedling and radiofrequency (RF)–enhanced microneedling have become increasingly popular in aesthetic medicine for improving skin texture, reducing wrinkles, and stimulating collagen. However, on October 15, 2025, the U.S. Food and Drug Administration (FDA) issued an important Safety Communication regarding RF microneedling devices. It’s essential for patients considering these treatments to understand the FDA’s concerns, what they mean for you, and how to make safer, more informed decisions about your care.
The FDA’s Safety Communication notes that serious complications have been reported with certain uses of RF microneedling devices for dermatologic or aesthetic skin procedures. These reported adverse events include:
In some cases, injuries were severe enough to require surgical repair or medical intervention.
Importantly, the FDA emphasizes that these devices deliver radiofrequency energy beneath the skin, and that microneedling with RF is considered a medical procedure, not a simple cosmetic treatment. This underscores the importance of clinical oversight and expertise when these devices are used.
RF microneedling combines traditional microneedling with the delivery of radiofrequency energy into deeper layers of the skin. The addition of heat is intended to enhance collagen stimulation and tissue remodeling beyond what microneedling alone can achieve. However, with increased depth and energy comes increased complexity and potential risk.
While RF microneedling remains a useful tool in skilled hands, the recent FDA communication reflects that the safety outcomes vary significantly depending on who performs the procedure, the device used, and how it is operated.
One of the key messages from the FDA and professional medical organizations is that complications are more likely when RF microneedling is performed by individuals without proper medical training or in non-medical settings. Devices should only be used by licensed health care providers with specific training and experience in RF microneedling technology.
An experienced dermatologist or aesthetic surgeon not only understands facial anatomy at a deeper level, but can also adjust treatment parameters safely and respond effectively if complications occur. This level of care is essential for minimizing risk and optimizing outcomes in any energy-based treatment.
If you are considering RF microneedling or have a consultation scheduled, keep these points in mind:
Healthcare professionals are encouraged to report any complications to the FDA’s MedWatch program, which helps the agency track safety patterns and guide future recommendations.
The FDA Safety Communication is not a ban on RF microneedling, but a reminder that medical-grade aesthetic procedures should be taken seriously. With careful patient selection, appropriate device use, and experienced hands, RF microneedling can still be a valuable part of skin rejuvenation. However, prioritizing safety and clinical judgment will always remain the most important factor in achieving beautiful, lasting results.
If you have questions about whether RF microneedling is right for you, or want to explore alternative treatments, schedule a consultation with Dr. Rahban to determine the best, evidence-based approach for your individual skin goals.
When Dr. Rahban does a consultation with a prospective patient, he wants it to be two things above all others: thorough and honest. He will find out from you just what you want from cosmetic surgery. And he will tell you honestly if you can get the result you want, and how he can best help you do so.
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