The following data is part of a premarket notification filed by Fotona D.d. with the FDA for Lightwalker At Lightwalker Dt Lightwalker St-e Lightwalker St-n.
| Device ID | K121508 |
| 510k Number | K121508 |
| Device Name: | LIGHTWALKER AT LIGHTWALKER DT LIGHTWALKER ST-E LIGHTWALKER ST-N |
| Classification | Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis |
| Applicant | FOTONA D.D. STEGNE 7, Ljubljana, SI 1210 |
| Contact | Stojan Tost |
| Correspondent | Stojan Tost FOTONA D.D. STEGNE 7, Ljubljana, SI 1210 |
| Product Code | PDZ |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-21 |
| Decision Date | 2012-12-12 |
| Summary: | summary |