RF Microneedling Safety: What You Need to Know & Why illumeMD Clients Can Feel Confident

On October 15, 2025, the U.S. Food and Drug Administration (FDA) issued a communication regarding reports of serious complications associated with some uses of RF microneedling devices. These complications included:

  • Burns

  • Scarring

  • Unintended fat loss

  • Skin texture changes or disfigurement

  • Nerve injury requiring medical treatment or surgical correction

The FDA emphasized that RF microneedling is a medical procedure, not a cosmetic spa treatment, and should only be performed by trained, licensed healthcare professionals using FDA-cleared devices.

The concerns highlighted by the FDA primarily relate to:

  1. Use of devices that are not FDA-cleared, and

  2. Use by providers without proper medical training who may not understand how to adjust depth, heat settings, or skin-type–specific risk factors.

The FDA is continuing to review data and is asking both patients and clinicians to report any complications so the agency can better define risks and best practices.

How This Relates to Care at illumeMD

The Pixel-8 RF system used at illumeMD is FDA-cleared through the 510(k) process. This means it has undergone regulatory review to demonstrate:

  • Safety of its microneedle design

  • Controlled heat delivery

  • Predictable depth and energy settings

Just as importantly, every RF microneedling treatment here is physician-led by our doctor who has trained in aesthetics and regenerative skin physiology.

This directly aligns with the FDA’s patient recommendations, which advise:

  • Seeking treatment from licensed medical professionals

  • Confirming the device being used

  • Discussing personalized risks and benefits

These practices are standard at illumeMD.

Why This Matters for Your Skin

RF microneedling can be transformative when:

  • The device is cleared

  • The provider understands skin biology

  • The treatment parameters are personalized

This is especially true for melanin-rich skin, where improper settings increase risk of:

  • Hyperpigmentation

  • Hypopigmentation

  • Overheating injury

At illumeMD, we tailor energy and depth specifically to your skin, evaluating:

  • Inflammation sensitivity

  • Healing response

  • Melanin index

  • Collagen density and age-related changes

We do not believe in aggressive settings for quick visual “wow.”
Our philosophy is collagen remodeling, not tissue trauma.

In Conclusion ...

The FDA’s communication reinforces what we have always believed at illumeMD — RF microneedling is powerful and effective, but only when combined with the right device, the right hands, and the right respect for the skin.

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