The following data is part of a premarket notification filed by Ulab Systems, Inc. with the FDA for Ulab Systems Treatment Planning Software.
| Device ID | K171295 |
| 510k Number | K171295 |
| Device Name: | ULab Systems Treatment Planning Software |
| Classification | Orthodontic Software |
| Applicant | ULab Systems, Inc. 101 Jefferson Drive, Suite 212A Menlo Park, CA 95025 |
| Contact | Charlie Wen |
| Correspondent | Charlie Wen ULab Systems, Inc. 101 Jefferson Drive, Suite 212A Menlo Park, CA 95025 |
| Product Code | PNN |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-02 |
| Decision Date | 2018-01-09 |
| Summary: | summary |