FDA 483 - Lightwave - October 22, 2025

An FDA inspection of Medaesthetics International, LLC (dba Lightwave) in Phoenix, AZ, a manufacturer of Class II LIGHTWAVE light therapy systems, revealed extensive deficiencies across its quality system. The firm lacked established procedures for critical areas such as design control, process control, nonconforming product, complaint handling, CAPA, device records, labeling, purchasing, audits, management review, equipment calibration, UDI, document control, and software validation. These systemic failures indicate a severe lack of control over the manufacturing and quality assurance processes for their medical devices.