ILUMIEN OPTIS
System, Imaging, Optical Coherence Tomography (oct)
LIGHTLAB IMAGING, INC.
The following data is part of a premarket notification filed by Lightlab Imaging, Inc. with the FDA for Ilumien Optis.
Pre-market Notification Details
| Device ID | K123369 |
| 510k Number | K123369 |
| Device Name: | ILUMIEN OPTIS |
| Classification | System, Imaging, Optical Coherence Tomography (oct) |
| 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 | NQQ |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-01 |
| Decision Date | 2013-01-30 |
| Summary: | summary |
Trademark Results [ILUMIEN OPTIS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ILUMIEN OPTIS 86060599 4577531 Live/Registered |
LightLab Imaging, Inc. 2013-09-10 |
 ILUMIEN OPTIS 85763120 4576575 Live/Registered |
LightLab Imaging, Inc. 2012-10-25 |
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