The following data is part of a premarket notification filed by Fotona D.d. with the FDA for Fotona Dualis, Fotona Dualis Plus.
| Device ID | K011939 |
| 510k Number | K011939 |
| Device Name: | FOTONA DUALIS, FOTONA DUALIS PLUS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | FOTONA D.D. STEGNE 7, Ljubljana, SI 1210 |
| Contact | Mojca Valjavec |
| Correspondent | Mojca Valjavec 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 | 2001-06-21 |
| Decision Date | 2001-12-27 |
| Summary: | summary |