OPXION Optical Skin Viewer (OPXSV1-01F)

The OPXION Optical Skin Viewer is a non-invasive imaging system that uses Optical Coherence Tomography (OCT) technology to capture real-time, high-resolution images of external skin tissues. It produces two-dimensional cross-sectional, three-dimensional, and en-face images of tissue microstructures and is intended for visualization of skin anatomy across diverse patient populations.

Both the OPXION device and predicate (VivoSight) use near-infrared OCT technology with comparable axial and lateral resolutions. Key differences include: OPXION uses 840 nm wavelength versus predicate's 1305 nm; OPXION uses a superluminescent diode (6 mW) versus predicate's swept laser (≥25 mW); OPXION has faster scan speed (25 fps vs >6 fps); OPXION is significantly smaller and portable (2.1 kg) versus predicate's large stationary system (105 kg). Both achieve similar maximum scan range (5mm × 5mm) and axial depth (up to 2mm).

IEC 62304 (medical device lifecycle), IEC 60601-1 electrical safety, EN 60601-1, ANSI AAMI ES60601-1, IEC 60601-2-22 (particular standard for ultrasound), IEC/EN 60825-1 (laser safety), ASTM D4169-22 (packaging), ISO 10993-5 and 10993-10 (biocompatibility), IEC 62366 (usability), and IEC 60601-1-6 (usability and safety).

OPXION and the VivoSight predicate share identical intended use, target population, mode of action, and method of use. Both are non-invasive OCT systems for skin imaging producing comparable image quality and resolution. Technical differences (wavelength, light source type, power, size) do not raise new safety or efficacy concerns because: (1) both operate in near-infrared, which is established as safe in ophthalmology devices; (2) OPXION's lower optical power (6 mW vs 25 mW) actually provides a safety margin; (3) smaller size and portability do not affect imaging performance; and (4) clinical testing demonstrated image quality and anatomical visualization substantially equivalent to the predicate with no adverse events.