Cutera, Inc. a leading provider of laser, light and other energy-based aesthetic systems for practitioners worldwide, announced that its picosecond laser platform, enlighten, received US 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 optimisation 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 utilising 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.