Is RF-microneedling safe?

On October 15, 2025 the FDA in the United States issued a “Safety Communication” on RF microneedling procedures. RF microneedling is a very common aesthetic procedure widely available across the aesthetics industry. FDA communication of this kind is to provide consumers and practitioners with updated guidance about risks. The FDA has provided approval to many RF microneedling devices.  But approval to bring a device to market doesn’t necessitate a procedure is always safe and this communication emphasizes that fact. 

If anything, this FDA notice shines a light (once again) on the fact that aesthetic medicine is highly unregulated.  What regulation does exist varies greatly from jurisdiction to jurisdiction. 

What should Canadians learn from this FDA guidance? 

Buyer beware.   

Canada is a highly unregulated environment for medical aesthetics, worse than the United States. In part this is because Canada has a single payer health care system and all necessary medical care is subject to government regulation. By contrast, anything not covered by provincial health care plans or workplace dental/medical benefits is less regulated.  

This lack of regulation is particularly true for aesthetic medical lasers and energy-based devices.  In Ontario, for example, Class II, II and IV medical devices require Health Canada approval and adherence to the Canada Consumer Product Safety Act (CCPSA). But once a device is approved, that’s where the regulation and oversight ends. CCPSA enforcement is non-existent. Who can operate that device, how much training they should have, what environment they operate the machine in, how much insurance they have – all of this is poorly regulated and unenforced. 

This is why you see laser hair removal at a nail salon.  Or IPL in someone’s basement.  

Manufacturers of aesthetic devices try to indirectly regulate the industry for their own protection. They will only sell their device to a regulated professional such as a doctor or nurse practitioner.  But these devices can still end up for sale in the secondary ‘used’ market, and that’s where pretty much anyone can purchase a device. Then there’s the ‘knock off’ market. Copycat machines are manufactured and sold on Alibaba for example, and again who buys the machine is not regulated. Once you have the machine, you can set up shop. 

Regulating device use through the manufacturer or resale market just doesn’t work.  The only way to regulate the industry and make it safer for consumers is to regulate the device operator. This would involve regulating aesthetic laser technicians just the same way we regulate ultra sonographers, x-ray technicians, radiation therapists etc. A regulatory College would establish educational requirements, licensing, ongoing medical education (to stay up to date), oversight requirements and location standards for the work environment.   

But as it stands now – anyone can buy and run a Class II, II or IV laser, so – 

Buyer beware. 

And this is where the FDA’s Safety Communication comes in. RF Microneedling devices are FDA approved but with the understanding they will be properly operated. Given lax requirements for operators there are many reports of patients being burned, scarred, suffering fat loss, nerve damage and infections. Sometimes surgery is required to address these adverse outcomes. 

Any energy-based device is potentially dangerous in the wrong hands. Any device manufacturer who claims their device won’t cause injury/fat loss/scarring is making that claim based on appropriate use of the device under proper oversight and regulatory conditions.  

But what if the provider doesn’t know how to use the device properly?  Wasn’t trained by the manufacturer? Isn’t doing the required regular maintenance of the device to be sure it’s operating within factory specifications? Doesn’t have a medical professional providing oversight and care should something go wrong?  

Buyer beware.  

Bottom line is this – make sure you attend a medical clinic for energy-based treatments. These treatments are medical procedures.  Regulated professionals have a duty of care, and a College they report to. They have standards they must and do uphold. If your provider is a laser technician or medical aesthetician, ensure they are employed by a clinic that has a medical director (doctor of NP) ideally onsite. Ask about the technician/aesthetician’s training and experience. Look for those certifications being posted (where they completed their degree, does it include laser and light technology training, and their certifications from the manufacturer for that specific device).  

Will this mean the treatment is more expensive than at a spa, personal service establishment or salon? Yes, but often only marginally more expensive. A small price to pay to ensure one’s health and safety. And remember, ‘med’ or ‘medical’ in the business name doesn’t mean anything. Ask who the medical director is, their qualifications and whether they’re on site. 

The FDA warning is a wake-up call to the aesthetics industry, both consumers and providers. Let’s hope their guidance is heeded. 

Where does ArtMed stand on RF microneedling? 

At ArtMed, we don’t offer RF microneedling. But this is not because we consider it unsafe, we don’t offer it because we feel we have better treatment options from devices that are less painful, provide better and more predictable results and require less rounds of treatment.  

ArtMed is a medical clinic providing aesthetic medical procedures and related care. We purchase our energy-based devices new from the manufacturer, obtain training and certifications from them. We do regular preventive maintenance of our devices and ensure they are operating at peak performance levels. We always have an MD or NP on site, and our Medical Director is our Laser Safety Officer and we adhere to CCPSA standards. Our medical laser technicians all have higher education degrees or certificates in laser and light-based technologies in addition to device specific certifications.  And we’re all very experienced. 

As long as RF microneedling is provided under similarly stringent conditions, we believe it is safe. We provide this information so our patients (and anyone reading this blog) can be a wary buyer and make fully informed decisions about their care.