Ulthera obtains third FDA clearance for its ultrasound platform device

30 January 2014 (Last Updated January 30th, 2014 18:30)

US-based Ulthera has obtained the US Food and Drug Administration (FDA) approval for its Ulthera system to visualise the dermal and subdermal layers of tissue during the non-invasive lifting treatment.

US-based Ulthera has obtained the US Food and Drug Administration (FDA) approval for its Ulthera system to visualise the dermal and subdermal layers of tissue during the non-invasive lifting treatment.

The Ulthera system is reportedly the first and only energy-based device to receive the FDA clearance for a non-invasive aesthetic lift indication.

Ultherapy is an FDA-cleared non-surgical, non-invasive procedure to treat the face to encourage the natural formation of collagen and elastin in the skin, giving it the ability to lift tissue.

"Ultherapy is an FDA-cleared non-surgical, non-invasive procedure to treat the face to encourage the natural formation of collagen and elastin in the skin, giving it the ability to lift tissue."

Ultherapy uses ultrasound and the body's own natural healing process to lift, tone, and tighten loose skin on the brow, neck, and under the chin.

In September 2009 and October 2012, the company received the FDA clearances 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.

Ulthera president and CEO Matthew Likens said while the Ulthera system had already been cleared to safely image the face and neck, with this new, stand-alone clearance, it is now recognised as a tool to help providers visualise tissue layers while they are treating.

"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 said.

"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."

According to GlobalData estimates, the US general surgery market was valued at $4.16bn in 2012 and is expected to grow at a CAGR of 4.2% to reach $5.56bn by 2019.