Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

A Guide for Photobiomodulation Therapy for Alopecia

J Cosmet Laser Ther; 2018 Jun; Dodd, Winter, et al

Patients are increasingly seeking the advice of dermatologists regarding the safety and efficacy of hair loss treatments. The market for home-use photobiomodulation devices to treat androgenetic alopecia has rapidly expanded and the Food and Drug Administration (FDA) has recently cleared many devices for this purpose. The purpose of a recent clinician’s guide was threefold:

  1. to identify all home-use photobiomodulation therapy devices with FDA-clearance for treatment of androgenetic alopecia;
  2. to review device design, features and existing clinical evidence; and
  3. to discuss practical considerations of photobiomodulation therapy, including patient suitability, treatment goals, safety, and device selection.

A search of the FDA 510(k) Premarket Notification database was conducted using product code “OAP” to identify all home-use devices that are FDA-cleared to treat androgenetic alopecia. 13 commercially available devices were identified and compared. To date, there are no head-to-head studies comparing the efficacy of these devices although photobiomodulation therapy devices have an excellent safety profile and mounting evidence supporting their efficacy. As these devices become increasingly popular, dermatologists should be familiar with this treatment modality to add to their therapeutic armamentarium.


Dodd EM, Winter MA, Horinsky MK, Sadick NS, Farah RS. Photobiomodulation therapy for androgenetic alopecia: A clinician’s guide to home-use devices cleared by the Federal Drug Administration. J Cosmet Laser Ther. 2018;20(3):159-167. doi:10.1080/14764172.2017.1383613.