The following data is part of a premarket notification filed by Wavelight Laser Technologie Ag with the FDA for Burane Xl.
| Device ID | K050317 |
| 510k Number | K050317 |
| Device Name: | BURANE XL |
| Classification | Powered Laser Surgical Instrument |
| Applicant | WAVELIGHT LASER TECHNOLOGIE AG AM WOLFSMANTEL 5 Erlangen, DE 91058 |
| Contact | Alexander Popp |
| Correspondent | William J Sammons UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-02-09 |
| Decision Date | 2005-02-24 |
| Summary: | summary |