FDA 483 - CureWave Lasers, LLC - August 05, 2021

Curewave Lasers LLC, a medical device manufacturer in Dallas, TX, was inspected by the FDA, resulting in seven observations, many of which were repeat findings. The inspection revealed significant deficiencies in product certification, laser radiation measurement, calibration procedures, labeling, equipment maintenance, supplier control, and document control for their Class IV laser medical device, Medicor. These issues indicate a systemic lack of adherence to quality system requirements and performance standards.