FDA Clears Cynosure's Tattoo-Removal Device

Cynosure, a medical device manufacturer based in Westford, Massachusetts, received clearance from the United States Food and Drug Administration (FDA) for its PicoSure tattoo removal system. The PicoSure laser workstation is designed to remove benign pigmented lesions and permanent tattoos.

According to a press release by the company, a recent study showed 80 percent overall success rates for tattoo removal with the device. In addition, the study showed a success rate of 94 percent for the removal of green and blue pigment over a two week treatment regimen.

Michael David is CEO and president at Cynosure. In prepared remarks, he stated, "FDA clearance of PicoSure is a major milestone that caps nearly a decade of research and development at Cynosure to commercialize the world’s first safe and effective picosecond aesthetic laser specifically designed for the removal of tattoos and benign pigmented lesions.” He continued, "PicoSure accomplishes this by delivering short-pulse bursts of energy to the skin in trillionths of a second."

An estimated 45 million people in the United States currently have tattoos. Since these tattoos are often permanent reminders of poor judgement in the past, the market for tattoo removal in the U.S. is huge. According to information from the press release, approximately 20 percent of people with tattoos would like to get them removed. This leaves Cynosure with a potential market size of nine million in the U.S. alone.

References

www.cynosure.com/news-and-events/news.php?page=releasetxt&id=1764225