UNITY DX (UDX)

The UNITY DX is a non-contact ophthalmic imaging and analysis device that visualizes anterior and posterior ocular structures and measures biometric parameters including axial length, anterior chamber depth, central corneal thickness, and lens thickness. It also provides reference image functionality as an ocular image capture tool, intended for use by ophthalmologists, optometrists, and other eye-care professionals in clinical settings.

The UNITY DX uses hyperparallel OCT with a superluminescent diode light source at 840 nm, achieving >300K A-scans/second and 10.9 μm axial resolution in tissue. It incorporates OLED illumination for fixation/reference imaging, and includes wavefront measurement and reflective topography modalities. These characteristics differ from predicate devices but the differences do not raise new safety or effectiveness questions.

ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-10:2021 (biocompatibility); IEC 60601-1 Edition 3.2 and IEC 60601-1-2 Edition 4.1 (electrical safety and EMC); ISO 15004-1:2020 and ISO 15004-2:2007 (optical safety); IEC 62304:2015 (software lifecycle); IEC 62366-1:2020 (usability); ISO 14971:2019 (risk assessment).

UNITY DX demonstrates substantial equivalence through identical intended use (non-contact ocular imaging and biometric measurement) and comparable performance to predicate devices HP-OCT and IOLMaster 700. Clinical study of 159 subjects showed agreement and repeatability within pre-specified clinically acceptable bounds for all four measured parameters, with no adverse events reported. Non-clinical testing confirmed optical imaging performance, electrical/optical safety, and software reliability met or exceeded standards.