FDA 483 - CURALLAX LLC - April 17, 2019

Capillus LLC, a manufacturer of laser devices in Doral, FL, received an FDA Form 483 with five observations, many of which were repeats. The inspection revealed failures in submitting required product and supplemental reports for their Capillus devices. Additionally, the firm was cited for issues with product certification labels, identification labels lacking manufacturing dates, and improper reproduction of warning logotype labels in marketing materials.