Lutronic USA, LLC Earns US FDA Clearance For MOSAIC Fractional Laser System

Main Category: Medical Devices / Diagnostics
Also Included In: Dermatology;  Cosmetic Medicine / Plastic Surgery
Article Date: 26 Oct 2007 - 9:00 PDT

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Lutronic USA, LLC. announced that its MOSAIC fractional laser system has received US FDA 510(k) clearance for dermatological procedures requiring the coagulation of soft tissue. MOSAIC is an advanced aesthetic solution based on the latest in micro fractional technology that offers physicians an unprecedented combination of flexibility, precision and control for indications including scarring, sun-damaged skin and melasma.

"MOSAIC has proven to be an invaluable solution to physicians in markets throughout the world, and we are extremely pleased to have received clearance to market this breakthrough system in the United States," said Shaun Cave, President of Lutronic, USA, LLC. "This represents an important milestone in the continued growth and evolution of Lutronic USA, LLC and we look forward to continued growth in this market as we strive to deliver a full range of premier quality technologies and solutions to the clinical community."

MOSAIC employs Lutronic's patented Controlled Chaos Technology (CCT), which delivers multiple arrays of randomized microscopic laser beams to the skin. MOSAIC's unique "spray paint" approach eliminates the need for multiple linear passes and the clinical disadvantages of unavoidable overlap.

MOSAIC's patented CCT ensures that micro necrotic columns (MNCs) are sequentially delivered and sufficiently spaced apart to achieve a more natural, uniform treatment and prevent unnecessary bulk thermal damages often caused by conventional linear delivery methods. Affecting only a small portion of the total skin surface at each session, the MNCs stimulate a natural healing process to initiate long-term collagen remodeling and elastin regeneration. Excess necrotic pigment and coagulated cellular debris are then rapidly re-epithelialized as the skin heals.

MOSAIC's unique, user-friendly touch screen LCD interface and robust "flash" software further enhance physicians' ability to customize treatments for individual patient needs and achieve dramatic clinical improvements. MOSAIC's laser is optimized to allow operators to accurately count the total number of necrotic columns delivered to the skin through an Automatic Total Density Counter. This enables physicians to monitor the skin's reaction to treatment in real-time and, if necessary, adjust treatment parameters to minimize side effects and downtime, while ensuring optimal results.

MOSAIC's precision and flexibility are further illustrated by its Dual Operation Modes. MOSAIC offers physicians a choice between two modes of operation, and the ability to switch between the two during the same treatment in order to optimize results. The high speed Dynamic Mode continuously delivers randomized beams and sufficiently covers large areas on the face, neck and body very swiftly. The stamp-like Static Mode has the ability to instantly deliver 50 to 500 spots/cm2, and is suitable for smaller lesions or scars. With a choice of four different Skin Sensing Tips, Static Mode can be customized to treat lesions or scars of any size without causing thermal damage to the surrounding tissue.

Established in 1997, Lutronic has quickly emerged as one of the world's leading manufacturers of medical lasers. From the award-winning Spectra Line to the groundbreaking new MOSAIC System, Lutronic is committed to delivering innovative and effective technology for clinical and aesthetic professionals. Based in Seoul, Korea, Lutronic Corporation delivers premier quality laser systems to physicians, dentists and clinical professionals in 37 countries around the world. With nearly one third of its workforce dedicated to research and development and 20% of revenues reinvested in the development of new technologies, Lutronic Corporation is committed to remaining at the forefront of innovation in the medical technology field. Lutronic USA, LLC is headquartered in Princeton Junction, NJ, and maintains an extensive national network of distributors, including MedEdge and Eclipse Medical, who provide the company's award-winning products and technologies as well as servi! ce and support to physicians in North America.

http://www.lutronic.com

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