Medical Device Manufacturer · US , Rockville , MD

Lightlab Imaging, Inc. - FDA 510(k) Cleared Devices

10 submissions · 10 cleared · Since 2010

Recent clearances: OPTIS Metallic Stent Optimization E.4 SW, OPTIS Mobile System, OPTIS Integrated System Mobile Workstation

View 10 510(k) Devices ↓

10

Total

10

Cleared

0

Denied

FDA 510(k) Regulatory Record - Lightlab Imaging, Inc. Cardiovascular ✕

2 devices

1-2 of 2

Cleared Sep 19, 2014

ILUMIEN OPTIS, DRAGONFLY OPTIS IMAGING CATHETER

Cardiovascular · 109d

Cleared Aug 18, 2014

OPTIS INTEGRATED SYSTEM, DRAGONFLY OPTIS IMAGING CATHETER

Cardiovascular · 48d

Data Source

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

Last updated: Sep 15, 2026