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Beauty Device Brands Take Heed: Ulthera Fraud Suit Rooted In ‘FDA-Approved’ Versus ‘FDA-Cleared’

This article was originally published in The Rose Sheet

Executive Summary

The terms “FDA-approved” and “FDA-cleared” are not interchangeable; rather they denote distinct premarket regulatory pathways for medical devices with differing levels of FDA endorsement. Merz’s Ulthera unit recently failed to dismiss a false-advertising class action challenging its “FDA-approved” claims on an ultrasound system used in clinical settings for line and wrinkle treatment.


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