Fotona D.D. · Class II · Cleared Jul 11, 2014
| K-number | K132806 |
| Device name | FOTONA F-22 LASER HANDPIECE (F-RUNNER), FOTONA FS-01 LASER HANDPIECE |
| Applicant | Fotona D.D. |
| Product code | GEX |
| Device class | Class II |
| Decision date | Jul 11, 2014 |
| 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