FDAnews Device Daily Bulletin
Medical Devices / Inspections and Audits

Lexington International Cited for Faulty Laser Testing

April 25, 2018
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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, documenting the laser radiation safety testing.

However, the firm failed to record the results for the laser output power measurements.

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