The following data is part of a premarket notification filed by Fotona D.d. with the FDA for Fotona Xp Nd: Yag Laser System.
| Device ID | K113702 |
| 510k Number | K113702 |
| Device Name: | FOTONA XP ND: YAG LASER SYSTEM |
| Classification | Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis |
| Applicant | FOTONA D.D. STEGNE 7, Ljubljana, SI 1000 |
| Contact | Stojan Trost |
| Correspondent | Stojan Trost FOTONA D.D. STEGNE 7, Ljubljana, SI 1000 |
| Product Code | PDZ |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-16 |
| Decision Date | 2012-03-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03830054230231 | K113702 | 000 |