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Since Morpheus8 got the co-sign from the likes of Kim Kardashian (the Skims founder once praised this specific treatment for her six-pack), radio-frequency microneedling quickly became the treatment on everybody’s wish list. That was until last month, when the US Food Drug Administration began to question the treatment’s safety.
On October 15, 2025, the FDA issued a warning on the potential negative side effects that can arise when using RF microneedling devices. Those who have gone to a doctor for an RF microneedling session may be familiar with those downsides, but now the FDA is encouraging the public to be even more aware of these risks as they continue to grow in popularity.
“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,” reads the statement. “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.”
But why make this warning now? RF microneedling is not new, and devices such as Morpheus8, Potenza RF Microneedling, and many more have been out in the market for some time. Experts are unsure what made the FDA put out a statement on these treatments, but it may point to a bigger issue of misleading information and inadequate training when using the device.
What to Worry About
For those unfamiliar, RF microneedling is a treatment that delivers radio-frequency energy to the dermis layer of the skin through tiny punctures in hopes of smoothing wrinkles and treating scars. Daniel Belkin, MD, board-certified dermatologist at New York Dermatology Group, explains that when the skin is heated by the radio-frequency energy, it causes collagen to contract, and over time, your body responds to those tiny injuries by synthesizing new collagen.
One of the biggest benefits, Dr. Belkin says, is that this treatment penetrates into the dermis (the middle layer of skin) without disrupting the top layer (which many of the more aggressive treatments do). Typically, complications happen when the device is used incorrectly by someone who is not well-trained.
“There are many dangers of radio-frequency microneedling devices,” says Evan Rieder, MD, board-certified dermatologist and psychiatrist at 36 North Moore Dermatology. “The dangers include pain, bleeding, swelling, bruising, and infection. Longer term risks include burns, scars, never damage, discoloration (both lighter and darker color), stamp or track marks, and fat loss, especially with deeper treatments. There is also a concern that these treatments might fuse tissue planes that could make future plastic surgery procedures more complicated.”
There are also major misconceptions about what the treatment is actually for. Though it is often touted as a catch-all solution for many skin concerns, it is actually best when used only for certain specific issues. “One of the biggest issues with RF microneedling is that it is being marketed for so many different conditions, many of which RF microneedling has minimal to no evidence to help,” says Dr. Rieder.
Both Dr. Belkin and Dr. Rieder agree that RF microneedling is best used for smoothing fine lines and crepey skin, and treating any scarring and stretch marks (though Dr. Rieder argues that you would need to pair the treatment with other devices to better treat scars and stretch marks). Claims that RF microneedling can be used to contour and lift skin, treat hyperpigmentation, melasma, or rosacea, and tend to hair conditions or sweating are either not supported by enough studies or there are other treatments and devices that work better for those concerns.
“I tell people it s a maintenance thing,” says Dr. Belkin. “You may not notice a difference clinically. We re not necessarily going to improve the way your skin looks because it s not going to help you with your hyperpigmentation. It s not going to help you with your broken blood vessels. It s not going to help you with tightening. It s not going to help you with your oil [production or] your pores. It s not going to lift your cheeks. It s not going to give you volume. So you just have to set expectations.”
How to Stay Safe
There is no official recall of these devices, and experts say RF Microneedling is still generally considered safe. “It is a critical topic for us,” Konika Schallen, MD, senior vice president of global clinical operations and medical director of Candela and the Candela Institute of Excellence (CIE), tells Vogue. “And [it’s] important to know that not all RF microneedling devices are built the same.”
Looking for the right device is a good place to start when thinking about booking an appointment. Dr. Schallen emphasizes the safety of Candela’s RF microneedling device, the Matrix by Candela, as it measures how the skin responds to the energy emitted and helps practitioners adjust energy levels in real time to prevent damage as much as it can. “This intelligence prevents skin from overheating or other undesirable outcomes,” she says. “[It] delivers consistent, professional results that providers and their patients can trust.”
Dr. Belkin can attest to the efficacy of the Matrix by Candela’s and says it is the only RF microneedling machine that helps him understand the impedance (how the skin responds to energy) of the RF energy being used on a patient. He explains that the device can help monitor how a patient’s skin responds to heat and allow him to adjust how much energy to use so that he’s not causing more harm. Other devices, while deemed safe, don’t have these features. [Vogue reached out to other companies that make RF microneedling devices, such as InMode and Cynosure, for comment, but neither company got back in time for publication.]
But as with any treatment, it’s always best to go to an experienced practitioner. Dr. Rieder explains that RF microneedling has been quickly pushed into med spas and can be used by a range of practitioners that may or may not have a lot of experience with the device. “An aesthetic practitioner should have substantial experience, multiple different options to treat a given concern, and a deep understanding of treating complications,” he says. “Experience and training matter. Buyer beware.”
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