Nicht-invasive Körperformung mit Lichtgeschwindigkeit.
Hologic Receives FDA 510(k) Clearance to Market SculpSure® for Non-Invasive Body Contouring (Lipolysis) of the Submental Area (Under the Chin)

SculpSure Now Cleared to Treat Submental Area: Patients in Clinical Studies Report 100% Satisfaction Rate

MARLBOROUGH, Mass., Sept. 27, 2017 /PRNewswire

Hologic, Inc. (Nasdaq: HOLX) announced today that the U.S. Food and Drug Administration (FDA) has granted an expanded FDA 510(k) clearance for Cynosure’s non-invasive body contouring product, SculpSure®. The state-of-the-art body contouring laser treatment is now cleared to treat a double chin (also known as the submental area), marking the product’s sixth cleared body treatment area. SculpSure® is also cleared to treat the abdomen, love handles (flanks), back, and inner and outer thighs.

“Most patients in the 57-person clinical trial received two brief treatments six weeks apart,” said Dr. Lawrence Bass, board certified plastic surgeon and a principal investigator in the SculpSure clinical trials. “The short treatment time, 100% satisfaction rate, and dramatic contour reductions typically seen in the study patients give SculpSure the edge as the treatment of choice for the submental area.”

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