The following data is part of a premarket notification filed by Tomophase Corporation with the FDA for Tomophase Octis.
| Device ID | K102599 |
| 510k Number | K102599 |
| Device Name: | TOMOPHASE OCTIS |
| Classification | System, Imaging, Optical Coherence Tomography (oct) |
| Applicant | TOMOPHASE CORPORATION 14 BURGUNDY DRIVE Hampton, NH 03842 |
| Contact | Derek Beaupre |
| Correspondent | Derek Beaupre TOMOPHASE CORPORATION 14 BURGUNDY DRIVE Hampton, NH 03842 |
| Product Code | NQQ |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-10 |
| Decision Date | 2010-12-01 |
| Summary: | summary |