The FDA issued Boca Raton, Florida based medical devicemaker Lexington International a Form 483 for conducting laser radiation safety testing and distributing a medical device without recording the laser output measurements.

The manufacturer conducted a certification of its over-the-counter product HairMax LaserComb 82 low level laser therapy device indicated to promote hair growth. It documented the laser radiation safety testing but failed to record the results for the laser output power measurements and it released the product for distribution.