| K-number | K050317 |
| Device name | BURANE XL |
| Applicant | Wavelight Laser Technologie AG |
| Product code | GEX |
| Device class | Class II |
| Decision date | Feb 24, 2005 |
| Decision | Substantially Equivalent |
| Regulation | 878.4810 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov