FDAnews
www.fdanews.com/articles/83819-thermage-is-granted-regulatory-clearance-for-new-off-face-indication

THERMAGE IS GRANTED REGULATORY CLEARANCE FOR NEW OFF-FACE INDICATION

January 16, 2006

Thermage today announced that it has received regulatory clearance from the U.S. Food and Drug Administration (FDA) for a new indication of the ThermaCool system that enables clinicians to perform Thermage procedures off-face for the non-invasive treatment of wrinkles and rhytids. Until now, the ThermaCool system was indicated for use in the United States for periorbital region (forehead and area around the eyes) and the mid/lower face (cheeks, area around the mouth, chin, jowls, and jaw line).

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