Is Your Medical Provider Gambling With Your Face?


The Food and Drug Administration last week took a stand against sketchy aesthetic medical devices by codifying its classification order on microneedling. The action requires medical providers to use only devices that meet the FDA’s rigorous standards.

That’s great news for patients because the standards protect you from risks more common with non-cleared devices: adverse tissue reaction, cross-contamination and infection, electrical shock, and damage to underlying tissue.

“The implications are now crystal clear,” said Marc C. Sanchez, an FDA attorney who worked on Crown Aesthetics’s microneedling De Novo submission. “Microneedling devices pose a risk to patients which must be controlled by a device that the FDA has cleared.”

But patients won’t be protected unless their medical providers use an FDA-cleared microneedling device. As of March 1, there is only one FDA-cleared microneedling device: SkinPen® by Crown Aesthetics.

So any time you go in for a microneedling treatment, make sure it’s the FDA-cleared SkinPen (pictured above). Here’s an easy memory trick: “Blue is safe for you.”

After all, if it’s not SkinPen, your medical provider is gambling with your face.