The following data is part of a premarket notification filed by Fotona D.d. with the FDA for Fotona Xp Nd: Yag Laser System Family, Fotona Xp, Xp-2 Focus, Fotona Xp Changer,model Moo1-14f, Moo1-14f, Moo1-14f/2,.
| Device ID | K090126 |
| 510k Number | K090126 |
| Device Name: | FOTONA XP ND: YAG LASER SYSTEM FAMILY, FOTONA XP, XP-2 FOCUS, FOTONA XP CHANGER,MODEL MOO1-14F, MOO1-14F, MOO1-14F/2, |
| 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 | 2009-01-21 |
| Decision Date | 2009-06-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03830054230224 | K090126 | 000 |
| 03830054230170 | K090126 | 000 |