The following data is part of a premarket notification filed by Lightlab Imaging, Inc. with the FDA for Optis Mobile System.
| Device ID | K152120 |
| 510k Number | K152120 |
| Device Name: | OPTIS Mobile System |
| Classification | System, Imaging, Optical Coherence Tomography (oct) |
| Applicant | LIGHTLAB IMAGING, INC. 4 ROBBINS ROAD Westford, MA 01866 |
| Contact | Padmini Suravaram |
| Correspondent | Padmini Suravaram LIGHTLAB IMAGING, INC. 4 ROBBINS ROAD Westford, MA 01866 |
| Product Code | NQQ |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-30 |
| Decision Date | 2015-10-29 |
| Summary: | summary |