| K-number | K162191 |
| Device name | NAVILAS Laser System |
| Applicant | Od-Os GmbH |
| Product code | GEX |
| Device class | Class II |
| Decision date | Nov 22, 2016 |
| 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