Cutera Receives FDA 510(k) Clearance for Tattoo Removal for enlighten(TM)
BRISBANE, Calif., Nov. 6, 2014 (GLOBE NEWSWIRE) -- Cutera, Inc. (Nasdaq:CUTR), a leading provider of laser, light and other energy-based aesthetic systems for practitioners worldwide, announced that its picosecond laser platform, enlighten, received U.S. Food and Drug Administration 510(k) clearance for tattoo removal. In August, 2014, enlighten received clearance for the treatment of benign pigmented lesions.
“The FDA clearance for tattoo removal for enlighten signifies a critical milestone not only for Cutera, but for the advancement of picosecond laser technology in the aesthetics market. Consistent with our innovative design philosophy, enlighten features industry-leading laser and optical design with advanced micro-electronics. enlighten delivers highest pulse energy in its class, selectable pulse durations, and dual wavelengths allowing parameter optimization for tattoo removal. Our pivotal FDA study demonstrates the validity and utility of dual pulse durations for tattoo removal, and enlighten is the only picosecond laser platform incorporating this enabling feature. With this additional clearance, enlighten leads the next generation of multi-application picosecond laser platforms,” said Kevin Connors, President and CEO of Cutera, Inc.
“The use of picosecond laser technology in aesthetic practices is evolving. With enlighten, practitioners are much closer to utilizing a single device for the vast majority of tattoo removal procedures,” said Michael S. Kaminer, M.D., a board certified Dermatologist and Managing Partner of SkinCare Physicians in Chestnut Hill, Massachusetts, and one of the pre-eminent educators in cosmetic and aesthetic surgery. “I am pleased with my clinical experiences using enlighten, and am optimistic we will achieve better tattoo removal clearance in fewer treatment sessions compared to typical tattoo removal laser systems. The ability to independently adjust pulse duration, wavelength, and spot size while delivering therapeutic energy significantly advances tattoo removal therapy and treatment for benign pigmented lesions.”
Commercial shipments of enlighten are anticipated to commence in the fourth quarter, 2014.
About Cutera, Inc.
Brisbane, California-based Cutera is a leading provider of laser and other energy-based aesthetic systems for practitioners worldwide. Since 1998, Cutera has been developing innovative, easy-to-use products that enable physicians and other qualified practitioners to offer safe and effective aesthetic treatments to their patients. For more information, call 1-888-4CUTERA or visit www.cutera.com.
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995: Specifically, statements concerning the features, effectiveness, treatable conditions, timing of commercial sales, and the potential market size for Cutera’s new product, are forward-looking statements within the meaning of the Safe Harbor. Such forward-looking statements are subject to risks and uncertainties and may be affected by various factors that may cause actual results to differ materially from those in the forward-looking statements and those other factors described in the section entitled, “Risk Factors”, in Cutera’s most recent Form 10-Q as filed with the Securities and Exchange Commission on November 3, 2014. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Cutera undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date they were made, or to reflect the occurrence of unanticipated events.
CONTACT: Cutera, Inc. Ron Santilli Chief Financial Officer 415-657-5500 Investor Relations John Mills Integrated Corporate Relations, Inc. 310-954-1105 john.mills@icrinc.com
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