The following data is part of a premarket notification filed by Lightlab Imaging, Inc. with the FDA for Optis Integrated System, Dragonfly Optis Imaging Catheter.
| Device ID | K141769 |
| 510k Number | K141769 |
| Device Name: | OPTIS INTEGRATED SYSTEM, DRAGONFLY OPTIS IMAGING CATHETER |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | LIGHTLAB IMAGING, INC. 4 ROBBINS ROAD Westford, MA 01886 |
| Contact | Jeffrey Roberts |
| Correspondent | Jeffrey Roberts LIGHTLAB IMAGING, INC. 4 ROBBINS ROAD Westford, MA 01886 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-01 |
| Decision Date | 2014-08-18 |
| Summary: | summary |