Bellus Medical, a leader in medical aesthetics, announced today that the company has completed CE Mark registration for its proprietary SkinPen® Microneedling Cartridge, a state-of-the art device used with the SkinPen® Precision Microneedling Pen and Skinfuse® Lift Hydrogel.
SkinPen® Precision is a microneedling device that utilizes Collagen Induction Therapy (CIT) to treat Melasma, acne and surgical scars (CE Intended Use).
“Receiving the CE Mark represents a significant milestone for Bellus Medical,” said President and CEO Joe Proctor. “When we started Bellus Medical in 2012, our goal was to create a company that was patient-focused, as well as product-focused. Today, we are an industry leader, a trusted provider, and now we can share that same level of service and commitment with our new partners in Europe.”
CE marking is a medical device manufacturer’s claim that a product meets the essential requirements of all relevant European Medical Device Directives (MDD). The directives outline the safety and performance requirements for medical devices in the European Union (EU). The CE Mark is a legal requirement to place a device on the market in the EU. The CE mark shows that Bellus Medical has complied with The European Medical Device Directive 93/42/EEC regarding medical devices.
“The aesthetics community has eagerly anticipated the expected quality improvements of devices in the microneedling category, and we look forward to the SkinPen® brand’s broad adoption in Europe,” Proctor said. “Providing practices in Europe with a safe, reliable and effective device is an accomplishment we are proud of. We are committed to providing cutting-edge, safe and high-quality devices, and we are thrilled about the opportunity to expand this commitment across Europe.”
With its ISO 13485:2016 Certification and CE Mark, Bellus Medical is expected to launch the SkinPen® microneedling system into Europe this year.