The following data is part of a premarket notification filed by Fotona D.d. with the FDA for Fotona Xd-2 Diode Laser System, Model Md01-2f.
| Device ID | K083034 |
| 510k Number | K083034 |
| Device Name: | FOTONA XD-2 DIODE LASER SYSTEM, MODEL MD01-2F |
| Classification | Powered Laser Surgical Instrument |
| Applicant | FOTONA D.D. STEGNE 7 Ljubljana, SI 1210 |
| Contact | Stojan Trost |
| Correspondent | Stojan Trost FOTONA D.D. STEGNE 7 Ljubljana, SI 1210 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-10 |
| Decision Date | 2009-02-04 |
| Summary: | summary |