The following data is part of a premarket notification filed by Starmedtec Gmbh with the FDA for Vela Xl.
| Device ID | K103654 |
| 510k Number | K103654 |
| Device Name: | VELA XL |
| 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 | 2010-12-15 |
| Decision Date | 2011-04-06 |
| Summary: | summary |