The following data is part of a premarket notification filed by Starmedtec Gmbh with the FDA for Auriga Qi.
| Device ID | K121570 |
| 510k Number | K121570 |
| Device Name: | AURIGA QI |
| Classification | Powered Laser Surgical Instrument |
| Applicant | STARMEDTEC GMBH KREUZSTRASSE 22 Starnberg, DE 82319 |
| Contact | Gregor Weidemann |
| Correspondent | Gregor Weidemann STARMEDTEC GMBH KREUZSTRASSE 22 Starnberg, DE 82319 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-29 |
| Decision Date | 2013-01-16 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() AURIGA QI 85485913 4390371 Live/Registered |
BOSTON SCIENTIFIC LIMITED 2011-12-02 |