Since the first United States Food and Drug Administration (FDA) clearance of a laser device for the treatment of onychomycosis in 2010, a large number of diverse laser systems have also gained clearance in the following five years. However, there has been very little follow-up data on the cleared systems concerning: (a) proposed anti-fungal mechanism of action for the devices, (b) retrospective studies post-approval and (c) suggested best practice therapy updates. This lack of follow-up data has been heavily criticized within the dermatology and podiatric communities. To answer these concerns, we herein present a 7-year review of all the available data (published and (un-published) for the 870 nm/930 nm Noveon laser system collected over the years 2008-2015. This review will discuss published human pilot data from 2008, published pivotal trial data from 2010, published retrospective data from the pivotal trial in 2012, and data from the 199-patient retrospective study published in 2014. This review also includes: (i) un-published data describing in vivo mycologic testing, (ii) un-published pivotal trial data measuring nail growth rates, and (iii) a discussion of in vitro published and human un-published reports describing antifungal potentiation with the Noveon laser. Finally, we give a series of suggestions and clinician advice for best clinical practices, based on these 7 years of data generation.
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