FDA 483 - Light Age, Inc. - July 01, 2022

Light Age, Inc. received a Form 483 with 17 observations related to its Q-Clear device, indicating significant deficiencies across its quality management system. Issues include inadequate device master and history records, lack of proper process controls, and failures in equipment calibration, corrective actions, and complaint handling. These findings highlight a systemic non-compliance with medical device regulations, particularly 21 CFR 820.