The following data is part of a premarket notification filed by Fotona D.d. with the FDA for Fotona F-22 Laser Handpiece (f-runner), Fotona Fs-01 Laser Handpiece.
| Device ID | K132806 |
| 510k Number | K132806 |
| Device Name: | FOTONA F-22 LASER HANDPIECE (F-RUNNER), FOTONA FS-01 LASER HANDPIECE |
| Classification | Powered Laser Surgical Instrument |
| Applicant | FOTONA D.D. STEGNE 7, Ljubljana, SI 1000 |
| Contact | Stojan Trost |
| Correspondent | Stojan Trost FOTONA D.D. STEGNE 7, Ljubljana, SI 1000 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-06 |
| Decision Date | 2014-07-11 |
| Summary: | summary |