FDA approve PicoSure (Cynosure) pulsed laser system for treating Benign Pigmented Lesions

Cynosure has received FDA 510(k) clearance to market the PicoSure laser workstation for the removal of tattoos and Benign Pigmented Lesions. The approval is based on a study which demonstrated that treatment with the picosecond-pulsed laser system 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 BPL 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.