The following data is part of a premarket notification filed by Lap Gmbh Laser Applikationen with the FDA for Doradonova Mr3t.
| Device ID | K173926 |
| 510k Number | K173926 |
| Device Name: | DORADOnova MR3T |
| Classification | Accelerator, Linear, Medical |
| Applicant | LAP GmbH Laser Applikationen Zeppelinstrasse 23 Lueneburg, DE 21337 |
| Contact | Martin Pfabel |
| Correspondent | Martin Pfabel LAP GmbH Laser Applikationen Zeppelinstrasse 23 Lueneburg, DE 21337 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-26 |
| Decision Date | 2018-09-14 |
| Summary: | summary |