The following data is part of a premarket notification filed by Fotona D.d. with the FDA for Sp Dynamis, Sp Spectro, Xs Dynamis, Xp Dynamis, Xp Spectro.
| Device ID | K143723 |
| 510k Number | K143723 |
| Device Name: | SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro |
| 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 | 2014-12-29 |
| Decision Date | 2015-04-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03830054230217 | K143723 | 000 |
| 03830054230200 | K143723 | 000 |
| 03830054230125 | K143723 | 000 |
| 03830054230118 | K143723 | 000 |
| 03830054230101 | K143723 | 000 |