Apollo Medical Optics, Ltd.

Apollo Medical Optics, Ltd. specializes in dermatological optical coherence tomography (OCT) systems. These devices are designed for high-resolution imaging of skin layers and structures, aiding in dermatological diagnostics and monitoring. The primary focus is on systems like the ApolloVue S100 Image System, which provide detailed visualization for clinical assessment.

The company is headquartered in the United States. This location aligns with its regulatory focus on FDA compliance for its medical devices.

Apollo Medical Optics, Ltd.’s devices are listed under the FDA 510(k) premarket notification process and the FDA Unique Device Identification (UDI) system. These registries ensure traceability and compliance for Class II devices in the US market.

The company’s dermatological OCT systems fall under Class II medical device classification in the US. This classification is based on their intended use for diagnostic imaging, which requires special controls to ensure safety and effectiveness without needing the stringent premarket approval process of higher-risk devices.