Shedding Light on the FDA’s 510(k) Approvals Process: Low-Level Laser Therapy Devices Used in the Treatment of Androgenetic Alopecia

This document is a study that examines the FDA's 510(k) approvals process for low-level laser therapy (LLLT) devices used in the treatment of androgenetic alopecia (AGA). The study found that 47 LLLT devices received premarket approval from the FDA between January 1, 2000 and July 15, 2018. The devices primarily use red light with wavelengths ranging from 635-678nm and contain between 51-272 laser diodes ranging in power from 2-20mW per diode. Recommended treatment protocols range from 10-30 minutes/session, 2-7 sessions/week. The study also found that the target audience for these devices has expanded to include both men and women. However, the study notes that marketed indications have not been adequately explored and further research is needed to define appropriate practice guidelines for LLLT in the treatment of AGA.