The following data is part of a premarket notification filed by Fotona D.d. with the FDA for Lightwalker At, Model M021-5af/1, Lightwalker Dt, Model M021-5af/2, Lightwalker St-e, Model M002-6a/2, Lightwalker St-n.
| Device ID | K101817 |
| 510k Number | K101817 |
| Device Name: | LIGHTWALKER AT, MODEL M021-5AF/1, LIGHTWALKER DT, MODEL M021-5AF/2, LIGHTWALKER ST-E, MODEL M002-6A/2, LIGHTWALKER ST-N |
| 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 | 2010-06-30 |
| Decision Date | 2010-11-22 |
| Summary: | summary |