The following data is part of a premarket notification filed by Fotona D.o.o. with the FDA for Lightwalker Laser System Family.
| Device ID | K193661 |
| 510k Number | K193661 |
| Device Name: | LightWalker Laser System Family |
| 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 | 2019-12-30 |
| Decision Date | 2020-03-25 |