Medical Device Manufacturer · US , Newton , PA

Mauna Kea Technologies, Inc. - FDA 510(k) Cleared Devices

1 submissions · 1 cleared · Since 2011

Recent clearances: CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES

View 1 510(k) Devices ↓

1

Total

1

Cleared

0

Denied

FDA 510(k) Regulatory Record - Mauna Kea Technologies, Inc. General & Plastic Surgery ✕

1 devices

1-1 of 1

Cleared Aug 08, 2011

CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES

General & Plastic Surgery · 115d

Data Source

Sourced from the FDA 510(k) public files . 176,325 total devices indexed.

Last updated: Sep 15, 2026