Newly Approved Laser Systems for Onychomycosis

Aditya K. Gupta MD, PhD, FRCP (C), FAAD1,2 and Fiona Simpson HBSc2
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  • 1 Division of Dermatology, Department of Medicine, University of Toronto, Toronto, Canada.
  • | 2 Mediprobe Research Inc, London, Ontario, Canada.
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Laser systems are a new treatment area for onychomycosis. As of January 2012, the US Food and Drug Administration (FDA) has approved four laser systems for the “temporary increase of clear nail in onychomycosis.” The FDA has approved these devices on the basis of “substantial equivalence” to predicate devices with similar technical specifications and applications. Laser therapy appears to be a promising alternative to traditional pharmacotherapy, but these systems have been tested in only limited clinical trials; therefore, it is not possible to compare their efficacy to the oral and topical drugs currently used in the treatment of onychomycosis. (J Am Podiatr Med Assoc 102 (5): 428-430, 2012)

Corresponding author: Aditya K. Gupta, MD, PhD, FRCP (C), FAAD, 645 Windermere Road, London, Ontario, Canada N5X 2P1. (E-mail: