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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Hologic Receives CE Mark to Market SculpSure® for Non-Invasive Body Contouring (Lipolysis) of the Submental Area (Under the Chin)

Patients in Clinical Studies Report 100% Satisfaction Rate

MARLBOROUGH, Mass., Oct. 17, 2017 /PRNewswire

Hologic, Inc. (Nasdaq: HOLX) announced today that it has received an additional European Medical Device Directive (MDD) certification for SculpSure®, a state-of-the-art body contouring laser treatment. The device is now certified to treat a double chin (also known as the submental area), marking the product’s sixth certified body treatment area. SculpSure® is also certified to treat the abdomen, love handles (flanks), back, and inner and outer thighs.

The certification allows Hologic to place the CE Mark on SculpSure® double chin (submental) treatments for use in the European Union (EU) and its member states. The double chin (submental) treatment requires practitioners to purchase a simple laser attachment, which will allow the treatment applicators to fit seamlessly onto the area. Hologic’s Cynosure sales force will begin distribution immediately to interested practitioners.

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Cynosure GmbH
Dammtorwall 7a
D-20354 Hamburg
Tel.: +49 (0)40 36 00 66 56-0
Fax: +49 (0)40 36 00 66 56-8
infogermany@cynosure.com

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