SkinPen® Safety Goes International

The importance of the US Food and Drug Administration (FDA) clearance for devices like Bellus’ SkinPen® has spread to the United Kingdom.

The UK has recently taken note on the seriousness of using safe devices to perform microneedling treatments, and many medical directors believe that this is the correct decision.

Even though the regulatory requirements can differ, the health risks associated with microneedling are the same.

The FDA now defines a microneedling device as one using one or more needles to mechanically puncture and injure skin tissue for aesthetic use. The Administration believes that this change will enhance your access to innovative devices.

So what does this mean for patients like you? The risks to health associated with the use of microneedling devices shouldn’t be ignored but they can easily be prevented.

To protect yourself, it is important that you only see a provider using an FDA-cleared microneedling device. By finding a doctor that uses the first FDA-cleared device, SkinPen®, you can be sure to protect your safety.1

1See intended use, important safety information, and clinical trial details (data on file) at
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