The following data is part of a premarket notification filed by Fotona D.d. with the FDA for Sp Dynamis, Sp Spectro, Xs Dynamis, Xs Spectro, Xp Dynamis, Xp Spectro, Models M021-4af/3, M002-2a.
| Device ID | K101306 |
| 510k Number | K101306 |
| Device Name: | SP DYNAMIS, SP SPECTRO, XS DYNAMIS, XS SPECTRO, XP DYNAMIS, XP SPECTRO, MODELS M021-4AF/3, M002-2A |
| 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 | 2010-05-10 |
| Decision Date | 2011-07-01 |
| Summary: | summary |