Un análisis de revisión del proceso de aprobaciones 510(k) de la FDA para dispositivos electromagnéticos utilizados en la contorno corporal.
PMID: 30614316 ·
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Resumen
Introduction: Greater demand for noninvasive techniques to reduce cellulite and contour the body has led to the growth of electromagnetic and radiofrequency devices. In this study, we aimed to characterize the evolution and safety of electromagnetic devices marketed in the U.S. over the last two decades. Methods: We examined records from a U.S. FDA database documenting premarket approval of electromagnetic devices between January 1, 2000 and October 31, 2018. Additionally, we searched the Manufa
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