FDA 483 - Phoenix Thera-Lase Systems LLC - June 03, 2024

Phoenix Thera-Lase Systems LLC, a medical device specification developer in Dallas, TX, was cited for numerous significant quality system deficiencies during an FDA inspection. The firm lacked established procedures for critical areas such as design control, medical device reporting, nonconforming product, CAPA, complaints, process control, quality audits, management review, and training. Additionally, issues were noted with laser product certification, labeling, product reporting, and Unique Device Identifier (UDI) compliance for their Class IV Therapeutic Laser Systems.