Michelson Diagnostics, Ltd.

Michelson Diagnostics, Ltd. specializes in dermatological optical coherence tomography (OCT) systems. These devices use advanced imaging technology to capture high-resolution cross-sectional images of skin layers, enabling detailed clinical assessment. Their portfolio includes handheld and topical OCT systems, such as the VivoSight and VivoSight Dx Topical OCT System, which are specifically designed for skin diagnostics.

Michelson Diagnostics, Ltd. is headquartered in the United States. The company’s location ensures it operates within the regulatory framework of the FDA, which governs the classification and authorization of its dermatological OCT devices.

Michelson Diagnostics’ devices are listed in the FDA’s 510(k) premarket notification registry and the FDA’s Unique Device Identifier (UDI) system. These registries track devices that have undergone the required regulatory processes to demonstrate substantial equivalence to legally marketed predicates, ensuring compliance with U.S. medical device regulations.

Michelson Diagnostics’ dermatological OCT systems are classified as Class II devices under FDA regulations. This classification applies to devices that generally pose moderate risk and require special controls to ensure their safety and effectiveness, such as performance standards or post-market surveillance. Class II devices typically require a 510(k) premarket submission to demonstrate compliance with these controls.