The following data is part of a premarket notification filed by Lap Gmbh Laser Applikationen with the FDA for Thales 3d Mr Scanner.
| Device ID | K200907 |
| 510k Number | K200907 |
| Device Name: | Thales 3D Mr Scanner |
| Classification | Accelerator, Linear, Medical |
| Applicant | LAP GmbH Laser Applikationen Zeppelinstrasse 23 Lueneburg, DE 21335 |
| Contact | Martin Pfabel |
| Correspondent | Martin Pfabel LAP GmbH Laser Applikationen Zeppelinstrasse 23 Lueneburg, DE 21335 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-06 |
| Decision Date | 2020-06-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260590370754 | K200907 | 000 |
| 04260590370747 | K200907 | 000 |
| 04260590372345 | K200907 | 000 |
| 04260590372338 | K200907 | 000 |
| 04260590372383 | K200907 | 000 |
| 04260590372376 | K200907 | 000 |
| 04260590372369 | K200907 | 000 |
| 04260590372352 | K200907 | 000 |