A review of the FDA's 510(k) approvals process for electromagnetic devices used in body contouring

Abstract

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 Manufacturer and User Facility Device Experience (MAUDE) database for reports of adverse events.

Results: Thirty-one devices were approved from 2012–2018. Initially marketed to temporarily reduce muscle pain and cellulite, indications for these devices have expanded. The MAUDE database revealed 61 reports of adverse events including acute skin damage, dyspigmentation, infection, hair growth, scarring, and others.

Discussion: Although electromagnetic devices are gaining increasing public attention and marketed to be safe, the frequency and types of adverse events are not well-documented. Importantly, the MAUDE database has limitations including submission of incomplete, inaccurate, untimely, or unverified data make determining the true number of adverse events difficult. Further investigation is greatly needed to define appropriate parameters and outcomes for the use of electromagnetic devices in body contouring and skin enhancement.

Keywords:

• Electromagnetic devices
• premarket approval
• cellulite
• RF energy
• hair reduction
• laser skin resurfacing
• acne vulgaris
• facial wrinkles
• cutaneous lesions
• pigmented lesions
• vascular lesions
• Google Trends

Disclosure statement

The authors have no conflict of interest to declare.