The following data is part of a premarket notification filed by Lightlab Imaging, Inc. with the FDA for Ilumien, Drageonfly Optis Imaging Catheter.
| Device ID | K150237 |
| 510k Number | K150237 |
| Device Name: | ILUMIEN, Drageonfly OPTIS Imaging Catheter |
| Classification | System, Imaging, Optical Coherence Tomography (oct) |
| Applicant | LIGHTLAB IMAGING, INC. 4 ROBBINS ROAD Westford, MA 01886 |
| Contact | Erdie De Peralta |
| Correspondent | Erdie De Peralta LIGHTLAB IMAGING, INC. 4 ROBBINS ROAD Westford, MA 01886 |
| Product Code | NQQ |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-02 |
| Decision Date | 2015-05-05 |
| Summary: | summary |