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 |