FDA 483 - Sauna Works, Inc - December 10, 2025

Sauna Works, Inc. in Berkeley, CA, a manufacturer of medical devices including the Clearlight Red Light Therapy device, was inspected and found to have systemic and severe deficiencies across its quality system. The firm failed to establish fundamental procedures for design control, complaint handling, corrective and preventive actions, medical device reporting, purchasing controls, incoming product acceptance, labeling control, management review, and quality audits. These failures indicate a complete lack of a compliant quality system, with potential safety implications highlighted by an electrocution incident and recurring device malfunctions.