10/18/2025
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⚠️FDA
Risk of serious complications with RF microneedling devices
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.
• Morpheus
• Potenza
• Vivace
• Secret RF
• Exion
• Agnes RF
• Profound RF
• Sylfirm
• ULTRAcel
• Infini RF
Report any problems or
complications experienced from skin procedures with RF microneedling to the FDA.
🔺https://fda.com🔺
1-888-INFO-FDA (1-888-463-6332)
