Regulatory

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.

 

For further information about VivoSight™, please e-mail info.us@vivosight.com or telephone +1 (408) 504-7391