What is Radiofrequency (RF) Microneedling?
RF microneedling combines two methods: microneedles—tiny pins that briefly enter the skin—and RF energy, which creates controlled heat under the surface. The heat triggers new collagen and elastin, which can improve wrinkles, texture, and skin tightness.
Common Devices You May Hear About
- Morpheus8 (InMode)
- Genius RF (Lutronic)
- Potenza (Cynosure)
- Vivace / Vivace Ultra (Aesthetics Biomedical)
- Secret RF (Cutera)
Intended Results
Most patients hope to see smoother skin, fewer fine lines, and mild tightening. Results vary based on device, treatment settings, and provider experience.
FDA Safety Alert: October 15, 2025
The U.S. Food and Drug Administration issued a safety alert about potential risks linked to RF microneedling devices used for cosmetic and dermatologic purposes. The FDA received reports of serious complications including burns, scarring, fat loss, nerve damage, and disfigurement. Some patients required surgery or other medical care. The FDA’s review is ongoing, and the true frequency of these problems is currently unknown because reporting is voluntary.
Who Should Use Caution?
RFMN should only be performed by trained medical professionals. People with darker skin, a history of keloids, connective tissue disease, or implanted devices should discuss risks carefully before treatment.
How the FDA Regulates These Devices
Most RFMN systems are Class II medical devices cleared through the 510(k) process. This means they were found ‘substantially equivalent’ to an existing device, not that they underwent extensive clinical testing for cosmetic results. In contrast, drugs must pass multiple clinical trial phases showing safety and effectiveness before approval.
Safety Checklist for Patients
- See a board-certified dermatologist or facial plastic surgeon.
- Ask which device will be used and why it was chosen.
- Discuss risks, skin type considerations, and aftercare instructions.
- Avoid at-home RF microneedling devices.
- Report complications through FDA MedWatch.
References
- FDA Safety Communication: Potential Risks with Certain Uses of Radiofrequency (RF) Microneedling Devices (Oct 15, 2025).
- FDA: Microneedling Devices Overview. U.S. Food and Drug Administration.
- FDA: 510(k) Premarket Notification Overview. U.S. Food and Drug Administration.
- FDA: How Drugs Are Developed and Approved. U.S. Food and Drug Administration.
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