SkinPen® Precision Microneedling Device Receives FDA Clearance Making it the ONLY Class II Safe and Legally Marketed Microneedling System in the U.S.
Bellus Medical has been granted clearance and immediate marketing authorization by the U.S. Food and Drug Administration (FDA) for its medical grade microneedling device, SkinPen® Precision. 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 available.
SkinPen® Precision is the First and Only Medical Grade Microneedling Device Approved in Australia
Bellus Medical expands the skin-enhancing benefits of the industry-leading SkinPen® Precision in Australia! SkinPen® Precision is Bellus Medical’s flagship product, and now with approval from the Therapeutic Goods Administration (TGA), Bellus will partner with Advanced Skin Technology to distribute SkinPen® Precision to practitioners in Australia. TGA, the agency that regulates medical devices and pharmaceuticals in Australia, has approved the SkinPen® Precision microneedling system as a Class II medical device utilizing Collagen Induction Therapy (CIT) to treat Melasma, acne scars, and surgical scars.
Bellus Medical Launches Highly Anticipated New Product, Allumera
Bellus Medical is proud to launch Allumera, a breakthrough topical cream that’s the first in photodynamic cosmetics (PDC). Allumera is the first PDC cream specifically formulated to improve the overall appearance of skin, visibly reduce outward signs of aging, and minimize the appearance of pores.
7 Reasons to Choose Bellus Medical
Bellus Medical is honored to receive recognition in the aesthetic industry, topping the charts in seven categories presented by the Aesthetic Everything® 2017 Diamond Crystal Awards. Bellus is proud to be recognized for leading the charge in microneedling technology, commitment to excellences as a top aesthetic company and CEO leadership.
SkinPen® Precision Microneedling System Now Available in Canada
Bellus Medical is pleased to announce that SkinPen® Precision is now available to medical practitioners in Canada. With Health Canada’s Medical Device license Number 99476, Bellus will offer the complete SkinPen® microneedling system, including the SkinPen® Precision microneedling device, Skinfuse™ post-microneedling protocol and the Skinfuse™ treatment kit, to treat Melasma, acne, and surgical scars in Canada. The SkinPen® microneedling system raises the standard in technology and is backed by the highest medical device standards available to practices and their patients.
Bellus Medical Earns CE Mark for SkinPen and Accessories
We are excited to announce that Bellus Medical has completed CE Mark registration for our SkinPen® Microneedling Cartridge, SkinPen® Precision Microneedling Pen and Skinfuse® Lift Hydrogel. Specifically, this means Bellus can now sell our SkinPen® microneedling system commercially to physicians within the European Union. Providing practices in Europe with a safe, reliable and effective device is an accomplishment for which we are extremely proud.
Bellus Medical Earns ISO 13485:2016 Certification
Bellus Medical recently earned the ISO 13485:2016 certification and leads the industry with this important designation. It’s the best internationally-accepted model a medical device provider can implement to demonstrate compliance to laws and regulations of the medical device industry. Bellus is the first microneedling company to earn this designation!
Bellus Medical Appoints New Vice President of Sales
Bellus Medical welcomes Michael McKenna as the Vice President of Sales. This is a valuable addition to the executive leadership team, responsible for spearheading business development, strategic sales plans and positioning the company for continued growth and increased customer satisfaction.
Bellus Medical Expands Product Portfolio by Acquiring Allumera®
Bellus Medical acquired Allumera®, a breakthrough topical cream that’s the first in a new class of photodynamic cosmetics (PDC). Allumera® is the first PDC cream specifically formulated to improve the overall appearance of skin, visibly reduce outward signs of aging, and minimize the appearance of pores – all with minimal downtime and results that last. It’s applied by a healthcare professional and activated by a wide variety of light sources that include Red, Blue, IPL and PDL.
Bellus Medical to Provide Expertise at Key Events in 2017
Bellus Medical will have an increased presence at premier skin care and aesthetics tradeshow events across the U.S. this year. The company sets the standard for customer focus by providing blockbuster products like SkinPen®, Skinfuse®, Benzocaine Lidocaine Tetracaine (BLT) and ProGen™ PRP, all of which represent the highest quality, safety and efficacy in the industry. For this reason, Bellus Medical and its team of experts will take part in key events as it looks to increase in-person product education, expand customer reach and further position itself a leader in the medical aesthetics industry.
Bellus Medical Introduces Benzocaine, Lidocaine, and Tetracaine Product Line
Bellus Medical launched a line of non-invasive, over the counter numbing gels, Benzocaine, Lidocaine, and Tetracaine (B,L,T) packaged in convenient and easy-to-use individual packets. The single use, individual packets of B (Benzocaine, 20%), L (Lidocaine 4%) and T (Tetracaine 2%), are manufactured according to FDA OTC Drug monograph standards, eliminating the need for a prescription while still providing safe and effective levels of numbing ingredients.
Bellus Medical Launches New Product ProGen PRP
Bellus Medical introduced ProGen™ PRP, the latest innovation in the delivery of Platelet Rich Plasma (PRP). The scientifically-validated system is the most flexible kit in the marketplace that can deliver 2x and 5.1x PRP. The flexibility, combined with a reduction in procedure time and consistently repeatable results, offers the best value in the PRP market.
The Big Reveal: Bellus Medical Unveils New Look
Bellus Medical unveiled a new brand identity as it prepares for significant growth and elevates its position as a global brand. Since 2012, the company focused on building a solid foundation and since has experienced a steady, healthy growth. As the business needs evolve, the company continues to respond to consumer demand, and rebranding is part of that evolution.