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Medical Devices / Submissions and Approvals

FDA Grants Expanded Clearance to Zeltiq for CoolMini Applicator

Sept. 25. 2015
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The FDA has granted expanded clearance to Zeltiq Aesthetics to introduce its CoolMini applicator, which treats smaller pockets of fat, including the chin fat area.

The clearance is based on data from a U.S. clinical trial involving 60 male and female patients, between the ages of 22 and 65. Patients received one to two treatments in the area under the chin, resulting in an average of 20 percent fat reduction.

No significant adverse events were observed, and patients experienced little to no discomfort or downtime, the company says.

The Pleasanton, Calif.-based company says patients could see results in three weeks, while the most dramatic results occur one to three months after treatment. — Michael Cipriano