Cynosure has obtained expanded approval from the FDA for its SculpSure laser treatment. The device is now approved for removing abdominal fat cells. It was approved to remove fat cells in the flank area in May. A multicenter clinical study conducted by the company showed the device to be effective in reducing fat layer thickness in participants at six and 12 weeks after treatment.
The FDA has granted Syneron Candela expanded approval for its PicoWay, a picosecond laser previously approved for use in tattoo removal. The device can now also be used in the U.S. for the treatment of pigmented lesions. The firm said the device also obtained clearance from Health Canada for both indications.
The 532 nm Laser Delivery System, developed by Cynosure, has obtained clearance from the FDA. The system, which removes yellow, orange and red tattoo ink more efficiently, works with the firm's dermal repair device, PicoSure, which is used to treat acne scars, wrinkles, benign pigmented lesions and tattoos. The product is expected to be available in the second quarter.
Tattoo ink can hide a malignant melanoma, and laser tattoo removal might encourage precancerous lesions to become malignant, doctors at Laserklinik Karlsruhe in Karlsruhe, Germany, say. The doctors report a case study of a man who refused to have a nevus excised before undergoing laser-assisted tattoo removal, only to find later that the lesion was malignant. "[T]attoos should never be placed on pigmented lesions; if they are, the tattoos should not be treated by laser," the authors write.
The FDA approved a lidocaine/tetracaine topical anesthetic cream from Nuvo Research and Galderma for superficial aesthetic procedures such as removing tattoos, injecting fillers or resurfacing using lasers. Possible side reactions include erythema, skin discoloration and edema.