Cynosure Wins FDA 510(k) Clearance for SculpSure
Cynosure’s SculpSure — the first hyperthermic laser treatment for noninvasive lipolysis of the flanks — has gained FDA 510(k) clearance, the Westford, Mass., devicemaker announced Tuesday. The company plans a product launch later this year.
Consisting of an applicator system capable of targeting many parts of the body, the hands-free device disrupts subcutaneous fat cells without the need for surgery. Treatment takes about 25 minutes for an individual area, the devicemaker says.
During a multicenter clinical trial, patients demonstrated a significant reduction in fat layer thickness during six- and 12-week follow-ups, the company claims.
Last year, the WHO estimated 1.3 billion adults were overweight. — Jason Scott