Cynosure receives FDA approval for first picosecond laser to remove tattoos, benign pigmented lesions

Laser aesthetic treatment developer Cynosure (NASDAQ:CYNO; Westford, MA) recently received FDA clearance to market its PicoSure picosecond laser workstation for removing tattoos and benign pigmented lesions. The company expects to sell the system, which is the first of its kind for this purpose, initially through its US direct sales force to aesthetic dermatologists and plastic surgeons early this year.

The system delivers short-pulse bursts of energy to the skin in trillionths of a second to erase tattoo pigment more efficiently. Roy Geronemus, MD, director of the Laser & Skin Surgery Center of New York (New York, NY), performed a study in which 22 subjects with multicolored and recalcitrant tattoos were treated with the system over a two-week period. The results demonstrated greater than 80% overall tattoo clearance. On average, 94% clearance was achieved for blue and green ink. What's more, it allows for improved recovery time due to less collateral injury to surrounding tissue, explains Geronemus.

A study led by dermatologists Kenneth A. Arndt, MD, and Jeffrey Dover, MD, directors of SkinCare Physicians (Chestnut Hill, MA), focused on demonstrating that treatment with a picosecond laser improved clearance of benign pigmented lesions and tattoos with reduced side effects and fewer treatments than other lasers. A total of 15 subjects with tattoos and five subjects with benign pigmented lesions were enrolled in the study. Follow-up was conducted at one month and three months after the last treatment. The study found that 100% of the pigmented lesions were cleared by two treatments, and that tattoo clearance of greater than 75% was achieved in 75% of patients within three to four treatments.

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