Mauna Kea Technologies - FDA 510(k) Cleared Devices

Mauna Kea Technologies, is a medical device company specializing in real-time cellular imaging systems. The company develops the Cellvizio® platform, which uses confocal laser endomicroscopy technology to enable in vivo visualization during endoscopic and surgical procedures. The company maintains a manufacturing facility in Paris, France.

Mauna Kea Technologies has received 18 FDA 510(k) clearances from 18 total submissions, with no denied submissions on record. The company's regulatory focus has centered on General & Plastic Surgery devices, which account for 94% of its submission activity. Clearances span from 2005 to 2022, establishing a 17-year regulatory history. The company is currently inactive, with no new clearances since 2022.

The Cellvizio platform and its associated confocal miniprobes represent the core of the company's cleared device portfolio. These systems are designed for use across multiple clinical specialties, including gastroenterology, pulmonology, and urology, supporting applications in Barrett's esophagus, pancreatic cyst evaluation, and colorectal lesion assessment.

Explore the complete regulatory record, including specific device names, product codes, and individual clearance dates, in the 510(k) database.

510(k) submissions have been managed by Daniel & Daniel Consulting as regulatory consultant.