MESA, AZ–(Marketwired – Jan 30, 2014) – Ulthera, Inc. — a global medical device company focused on developing and commercializing technologies for aesthetic and medical applications — announced today that its ultrasound platform device, the Ulthera System, has been cleared by the Food and Drug Administration (FDA) to visualize the dermal and subdermal layers of tissue during the non-invasive lifting treatment, Ultherapy.
This marks the third FDA clearance the Ulthera System has received. The first two — in Sept. 2009 and Oct. 2012 — cleared the Ulthera System to non-invasively treat the face and neck with specific, first-and-only indications to lift skin on the neck, under the chin and above the brow.
“While the Ulthera System had already been cleared to safely image the face and neck, with this new, stand-alone clearance, it is now officially recognized as a tool to help providers visualize tissue layers while they are treating,” said Matthew Likens, president and CEO of Ulthera. “This ability to ‘see while you treat’ is unique in the aesthetics category and is an asset to providers performing the treatment to ensure optimal treatment experiences for patients.”
Likens continued, “This clearance demonstrates Ulthera’s continued commitment to advancing the Ulthera System and underscores our dedication to add more value to the platform during each year of physician ownership. Providers and patients recognize ultrasound as a major factor in aesthetics, and Ultherapy is at the forefront of that movement.”
For details on the Ulthera System’s indications for use, visit www.ultherapy.com/IFU.
Ulthera, Inc. is a global medical device company focused on developing and commercializing technologies for aesthetic and medical applications using its therapeutic ultrasound platform technology. The Ulthera® System is the first and only energy-based device to receive U.S. FDA clearance for a non-invasive aesthetic lift indication. It is used in a face and neck procedure known as Ultherapy®, which is an FDA-cleared treatment to lift skin above the brow, on the neck and under the chin. Founded in 2004 and based in Mesa, Ariz., Ulthera is a privately held company. For more information, visit www.ultherapy.com.
- Media Contact: