Cynosure, a leader in laser- and light-based aesthetic treatments for non-invasive and minimally invasive applications, announced that it has received clearance from the China Food and Drug Administration (CFDA) to market the PicoSure 755 nm wavelength for tattoo removal.
The product will be marketed through the Company’s direct sales force in China.
"This CFDA clearance further advances our strategy to establish PicoSure as a truly global brand for cosmetic medicine of the face and body," said Cynosure CEO Michael Davin.
"While our initial focus in China will be tattoo removal, we also are pursuing additional PicoSure clearances for skin rejuvenation and the removal of benign pigmented lesions, indications which we believe will generate significant interest among the country’s aesthetic physicians and patients."
"We expect strong demand for PicoSure to continue as we secure new international regulatory registrations and gain clearances in additional indications," Davin said.
PicoSure’s ultra-short pulse duration goes beyond photothermal action to create an intense photomechanical impact that results in greater disruption of the target for better clearance with fewer treatments, less fluence and without injury to the surrounding skin.
The product effectively treats tattoos as well as previously treated, recalcitrant tattoos.
The 755 nm PicoSure wavelength received U.S. FDA clearance in the fourth quarter of 2012 for the removal of tattoos and benign pigmented lesions, and was subsequently cleared for marketing in Canada, Australia, Korea and Taiwan.
Cynosure designs, manufactures and markets medical devices for aesthetic procedures and precision surgical applications worldwide.