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CoolSculpting System
In April 2017, a class-action lawsuit was filed against Zeltiq Aesthetics for allegedly deceptively marketing the CoolSculpting System (a “non-surgical fat reduction treatment” that allegedly “uses controlled cooling to eliminate unwanted fat cells”) as being “cleared” by the FDA to make consumers believe that the treatments have gone through the rigorous approval process when they have not. According to the plaintiffs, the FDA has given the product premarket notification clearance – meaning that the FDA has found a new medical device to be similar to another device that was already on the market before May 28, 1976 – and not premarket FDA approval, which requires testing and trials and means the FDA endorses the safety and effectiveness of the product. (Otero et al v. Zeltiq Aesthetics, Inc., Case No. BC659192, Superior Court for the State of California – County of Los Angeles)
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