FDA Cleared Microneedling


FDA Clears SkinPen® Precision System as the ONLY Legally Marketed and Class II Micrdoneedling Device in the US!

Bellus Medical is thrilled to publicly announce we have been granted clearance and marketing authorization by the U.S. Food and Drug Administration (FDA) for our medical grade microneedling device, SkinPen® Precision, to be used exclusively by healthcare professionals.

This is the first and only microneedling device in the industry to receive this important designation from the FDA, and sets a new standard as the only recognized Class II microneedling device for aesthetic use.


SkinPen Microneedling FDA Approved


Protect Your Practice. Protect Your Patients.

Bellus Medical collaborated with some of the world’s leading experts in the medical aesthetics industry, dermatology and plastic surgery to help identify the safety risks associated with microneedling devices. This feedback, along with the SkinPen Precision clinical trials, helped Bellus Medical implement measures to prevent risks to healthcare providers and consumers.

See why Board-Certified Plastic Surgeon Dr. Jeff Angobaldo chose SkinPen Precision for his practice.


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Intended Use: SkinPen® Precision System is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in adults aged 22 years or older.