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  1. Home
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  3. Cynosure Lutronic Announces Completion Of Eu Mdr Approval
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  • 02 Feb 2026
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  • News Article

Cynosure Lutronic announces completion of EU MDR approval

Cynosure Lutronic, a global leader in energy-based aesthetic medical technologies, announces that Mosaic 3D™ has received CE Mark approval according to the European MDR , marking another important milestone in the global expansion of its advanced fractional rejuvenation platform.

Following its successful launch in selected international markets, Mosaic 3D™ continues to gain momentum thanks to its positive clinical adoption and growing interest from leading experts worldwide. Mosaic 3D™ represents the new generation of non-ablative fractional laser, offering higher energy and covering larger areas, while ensuring safety with minimal discomfort and recovery time for patients through:

3D Controlled Chaos Technology™ : Optimizes the distribution and depth of multi-depth microbeams, 3D CCT helps reduce the risk of massive thermal heating, allowing an increase in the coagulation volume of the treatment per seal, without sacrificing safety.
Integrated cooling system: Enables practitioners to safely and effectively treat the sensitive areas around the eyes and mouth. The integrated air cooling system flows through the handpiece to the unique cold-compression sapphire tips. This synergy reduces pain, redness, and swelling, and improves treatment efficacy, safety, and comfort.
Versatility : Creates a new look for the skin by enhancing neocollagenesis and neoelastinogenesis in the mid-dermis, resulting in revitalized, radiant skin*. With its improved metal rollers and new sapphire tips , MOSAIC 3D™ applies rollers and stamping on a single laser platform. The easy-to-use, air-cooled roller allows for efficient coverage and exceptional effectiveness, with 3D CCT stamping in hard-to-reach areas.
Solid clinical validation from key international opinion leaders

Mosaic 3D™ is currently used in clinical practice and in studies led by internationally renowned expert researchers, such as Dr. Guy Erlich (Israel), Professor Merete Haedersdal (Denmark) and Dr. Tatiana Kuznechenkova (UAE).

Dr. Guy Erlich commented:

"" Mosaic 3D™ introduces a new level of control and adaptability in fractional rejuvenation. In both clinical practice and ongoing studies, we are observing excellent tissue response and a high degree of treatment flexibility, making it a powerful platform for advanced rejuvenation indications .""

Professor Merete Haedersdal added:

""Our clinical study with Mosaic™ 3D, which analyzes how image analysis has allowed us to better understand laser-tissue interactions with Mosaic3D to optimize our patients' treatment protocols, has yielded very promising results. The data are being finalized for publication, and I look forward to presenting our findings to the international medical community at IMCAS 2026.""

Dr. Tatiana Kuznechenkova stated:

""After several weeks of clinical use, Mosaic 3D™ has delivered promising and very encouraging results. Its precision and adaptability allow for highly personalized treatments, which is reflected in both patient satisfaction and clinical outcomes.""

First European presentation at the Cynosure Lutronic Science and Laser Symposium

Mosaic 3D™ was presented at the Cynosure Lutronic Laser & Science Symposium 2025 in Faro, as an initial clinical knowledge-sharing session prior to the official launch, and received an enthusiastic response from the audience, comprised of industry experts.

Continued global expansion in IMCAS 2026

Following its EU MDR approval and successful launches in other regions, Mosaic 3D™ will be a key event at the IMCAS World Congress 2026 , where Cynosure Lutronic will host a scientific symposium led by Dr. Guy Erlich and Professor Merete Haedersdal: Mosaic 3D™ Presentation, Symposium: Redefining Non-Ablative Fractional Lasers (NAFL). The symposium will be held on Friday, January 30, at 3:45 p.m. in Room 351 on Floor 3. It will focus on clinical data, treatment protocols, and real-world experiences with Mosaic 3D™, supported by additional educational and scientific activities throughout the congress.

Cynosure Lutronic remains committed to advancing evidence-based innovation and developing cutting-edge technologies that empower healthcare professionals and improve patient outcomes worldwide.

Acerca de Cynosure Lutronic 

With over 30 years of innovation and leadership in energy-based devices, Cynosure Lutronic empowers dermatologists, plastic surgeons, and aesthetic professionals worldwide to offer non-invasive and minimally invasive treatments. The company offers one of the most comprehensive product portfolios in the industry, encompassing skin rejuvenation, revitalization, hair removal, vascular treatments, toning, and body contouring. Cynosure Lutronic operates through direct sales in the United States, Canada, Germany, Spain, the United Kingdom, Australia, China, Japan, and Korea, and through distributors in approximately 130 countries worldwide.

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