Fotona D.O.O. · Class II · Cleared Oct 31, 2018
| K-number | K182088 |
| Device name | XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro |
| Applicant | Fotona D.O.O. |
| Product code | GEX |
| Device class | Class II |
| Decision date | Oct 31, 2018 |
| 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