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Regulatory status

Regulatory status

The VivoSight™ topical OCT system is indicated for use in the two-dimensional, cross-sectional, real-time imaging of external tissues of the human body.

This indicated use allows imaging of tissue microstructure, including skin, to aid trained and competent clinicians in their assessment of a patient’s clinical conditions.

US Federal law restricts this device to sale by or on the order of a physician. VivoSight is cleared under 510(k) number K153283. Internationally, VivoSight is also a CE marked product and has TGA approval, amongst other approvals. To download our User Manual – click here.

For further information about VivoSight™ and its regulatory approvals for your country, please e-mail or telephone +44 208 208 1695

Historical User Manuals – click here

VivoSight Dx Product shot 3/4 shot with display of skin imaging