An Analysis of Marketing Trends for the Approval of Cryolipolysis Devices by the United States Food and Drug Administration

摘要

Introduction: Cryolipolysis is a noninvasive technique that involves the application of cooling for localized fat reduction. In recent years, cryolipolysis has been increasingly favored for its limited side effects compared to more invasive methods. Methods: Records from a public United States Food and Drug Administration (FDA) database for premarket approval of cryolipolysis devices approved between January 1, 2000 and July 15, 2018 were reviewed. Results: Eleven devices received 510(k) premarket approval, with an increasing number of devices available since 2012. In addition, product indications have recently been expanded for use in patients with body mass index (BMI) values of up to 43kg/m 2 . Conclusion: The number of approved cryolipolysis devices has increased, with more companies exploring the technology’s growth potential in the market. Furthermore, use in patients with higher body mass index values is now permitted and expanding; however, indications are not well studied, and these marketed devices might misinform consumers and distort clinical expectations. Additional research to delineate specific practice guidelines for cryolipolysis is necessary.