It’s July, and at Crown Aesthetics that means only one thing: Christmas!
We picked gifts from around the tree, listened to heavy metal carols, and waited in anticipation for the traditional holiday meal from…Romano’s Macaroni Grill. (The spicy meatballs alone put Aunt Edna’s turkey to shame.)
If you’re wondering why we’re celebrating in the middle of summer, it’s because each month tops the last since the FDA made SkinPen® the first — and still the only — cleared #microneedling device.
That’s important because microneedling – the mechanical process of using tiny needles to create thousands of “micro” channels in the skin to stimulate the natural healing and remodeling process – needed a thorough cleanup. Though it’s been safely used by medical professionals for a wide variety of skin conditions since the 1990s, the treatment suffered from little oversight and frequent abuse.
But the FDA’s recent clearance of SkinPen established a new microneedling classification and category, making it the only legally marketed microneedling device with the correct classification.
SkinPen’s intended use is to improve the appearance of facial acne scars of people 22 years and older. Patients say the device simply works: Some 90% of subjects in a clinical trial said they would recommend the treatment to friends and family.
Our device gets those results through new technology. Its variable depth settings and cordless design provide significant versatility. As a result, physicians can adjust the treatment as appropriate for different areas of the face, as skin thickness can differ from area to area, and to fit the individual needs on each patient’s skin.
If making a category-creating medical device that patents and doctors love doesn’t call for a heavy metal rendition of “I’m Dreaming of a White Christmas” and some spicy meatballs, we’re not sure what does!
See intended use, important safety information, and clinical trial details (data on file) at bellusmedical.com.