FDA approves Lutronic's Mosaic eCO2 fractional laser system

July 14, 2008 -- Lutronic (Seoul, Korea and Princeton Junction, NJ), developer and manufacturer of aesthetic and medical laser systems, has received regulatory clearance from the FDA for its Mosaic eCO2 fractional laser. The system is designed to offer a safe treatment of deep ablative indications, and enables customization.

July 14, 2008 -- Lutronic (Seoul, Korea and Princeton Junction, NJ), developer and manufacturer of aesthetic and medical laser systems, has received regulatory clearance from the FDA for its Mosaic eCO2 fractional laser system.

According to Dr. J. David Holcomb, immediate past president of the Florida Society of Facial Plastic Surgeons, "the eCO2 is a familiar wavelength in an extremely elegant and versatile package, with the ability to perform incisional surgery, traditional ablative resurfacing and ablative microfractional photothermolysis." The system competes with fractional laser offerings from several other equipment makers, some of which target very specific uses.

Using Lutronic's proprietary Controlled Chaos Technology (CCT), this next generation fractional CO2 laser is designed to offer a safe and innovative way to treat deep ablative indications such as resurfacing and coagulation of soft tissue, textural irregularities, fine lines, pigmented lesions, vascular dyschromia, and rhytides. The eCO2 has several features that offer customizable treatments that promise ease of use and diminished pain for patients.

Of particular interest to many is the ability to combine two operational modes in one delivery system, which is important when deep penetration and greater patient comfort is required. With both Static and Dynamic operation modes, users have the capability to stamp up to a 14x14mm scan area as well as the option to "feather" the treatment area to reduce the "checkerboard" appearance that is common with currently available fractional CO2 devices.

Further, at a 120 micron spot size, initial biopsy studies indicate that the laser can penetrate as deep as 2.4mm into the dermis. "We are seeing long-lasting and consistent results after just one treatment with the eCO2 system. Preliminary results show that patients may not need a follow-up treatment," says Jhung Won Hwang, Ph.D., Sr. Director, Regulatory Affairs, Lutronic, Inc.

With several international and U.S. patents pending, the eCO2 has added multifunctional features, including an intuitive software that can select between a random or sequential beam pattern, as well as a built-in skin sensor technology that prevents the laser from firing unless the handpiece tip is in contact with the skin.

Last month, Lutronic received FDA approval for its Spectra VRM III dual pulse Q-Switched Nd:Yag laser.

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