Shedding light on the FDA's 510(k) approvals process: low-level laser therapy devices used in the treatment of androgenetic alopecia

Sophie Wang, Divya Seth, Harib Ezaldein, Raghav Tripathi, Miesha Merati, Fuad Muakkassa, Jeffrey Scott

Research output: Contribution to journalLetter


Introduction: Low-level laser therapy has demonstrated superior efficacy relative to other nonsurgical treatment options for the treatment of androgenetic alopecia. Methods: Records from a public U.S. FDA database for premarket approval of low-level laser therapy devices approved between January 1 2000 and July 15 2018 were reviewed. Results: 47 devices received 510(k) premarket approval, with an increasing number of devices available since 2007. More options are now available and product indications have expanded for use in a wider audience, including both men and women. Discussion: Growing recognition of lasers has led to an increasing number of devices available as well as innovative options in terms of design and convenience. In the past few years, these devices have adopted broader indications for use in both men and women. However, marketed indications have not been adequately explored and current devices on the market have the potential to mislead consumers.

Original languageEnglish (US)
Pages (from-to)489-491
Number of pages3
JournalJournal of Dermatological Treatment
Issue number5
Publication statusPublished - Jul 4 2019
Externally publishedYes



  • 510(k)
  • Androgenetic alopecia
  • hair growth
  • hair loss
  • low-level laser therapy

ASJC Scopus subject areas

  • Dermatology

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