FDA 483 - Apolo - Megasun LLC - August 29, 2024

Apolo - Megasun LLC, a manufacturer of photobiomodulation tables/beds in Saint Louis, MO, was cited for significant quality system deficiencies. Observations included inadequate finished device acceptance procedures, lack of unique device identifier (UDI) labeling, insufficient equipment calibration records, and a complete absence of design control procedures for their Class II medical devices. These issues indicate a broad failure to adhere to medical device quality system regulations.