The following data is part of a premarket notification filed by Fotona D.o.o. with the FDA for Fotona Xpulse Laser System Family (xpulse 1064 Nm, Xpulse 810 Nm, Xpulse 980 Nm).
| Device ID | K221712 |
| 510k Number | K221712 |
| Device Name: | Fotona XPulse Laser System Family (XPulse 1064 Nm, XPulse 810 Nm, XPulse 980 Nm) |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Fotona D.o.o. Stegne 7 Ljubljana, SI 1000 |
| Contact | Marko Berdajs |
| Correspondent | Marko Berdajs Fotona D.o.o. 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 | 2022-06-13 |
| Decision Date | 2022-10-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03830054230866 | K221712 | 000 |