Dermatology Online Journal

Acne vulgaris affects a large portion of the population and drives many patients to seek over-the-counter (OTC) treatments. Light-emitting diode (LED) therapy has recently emerged as a potential therapeutic option for inflammatory acne. We used the U.S. Food and Drug Administration (FDA) 510(k) premarket submission database to assess the growth in OTC LED therapy devices for treatment of acne. We also used Google Trends data in searches for "acne light therapy mask" to characterize growth in consumer interest in these devices. Overall, 35 LED devices received pre-market approval from 2000 to 2018, with a peak in approvals in 2016. Similarly, there was a dramatic increase in public interest in these devices in 2016. Only two devices were associated with company-approved trials. The current regulatory process requires little evidence to substantiate specified uses and a better understanding of practice guidelines and the efficacy of this treatment modality is required.