The following data is part of a premarket notification filed by Fotana D.o.o. with the FDA for Lightwalker Laser System Family.
| Device ID | K191554 |
| 510k Number | K191554 |
| Device Name: | LightWalker Laser System Family |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Fotana D.o.o. Stegne 7 Ljubljana, SI 1000 |
| Contact | Lina Rupnik |
| Correspondent | Lina Rupnik Fotana D.o.o. Stegne 7 Ljubljana, SI 1000 |
| Product Code | GEX |
| Subsequent Product Code | ILY |
| Subsequent Product Code | NVK |
| Subsequent Product Code | PDZ |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-12 |
| Decision Date | 2019-08-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03830054230996 | K191554 | 000 |
| 03830054230699 | K191554 | 000 |
| 03830054230347 | K191554 | 000 |