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# Allergan Expanded Use Cleared for CoolSculpting
- URL: https://www.fdaweb.com/allergan-expanded-use-cleared-for-coolsculpting/
- Published: 2018-10-04T12:00:00.000Z
- Updated: 2026-09-15T00:35:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142521

FDA has cleared an Allergan 510(k) for its CoolSculpting nonsurgical fat reduction device to treat the submandibular (below the jawline) area. In addition, FDA clearance was expanded to include patients with a BMI of up to 46.2 when treating the submental and submandibular areas. Clearance was based on data from a 22-week clinical study, which demonstrated an average 33% reduction in fat layer thickness after two treatments, the company says. Additionally, an average 85% patient satisfaction rate was reported across three studies, it adds.