Manufacturer
Fotona
SloveniaLegal entities : FOTONA, proizvodnja optoelektronskih naprav d.o.o.
Markets : Austria · Belgium · Bulgaria · Croatia · Cyprus · Czechia · Denmark · Finland · France · Germany · Greece · Hungary · Italy · Netherlands · Norway · Poland · Portugal · Slovenia · Spain · Sweden and 1 more countries
Approvals : EU – class IIa, IIb · United States (FDA) – 510(k) : 17 · class II · latest in 2026 · see on the FDA website
Public contracts won : France 1 · Slovenia 1
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
- Click a category to see competitors, a model to open its EUDAMED record.
| Category | EMDN code | Registered models | Class | Contact |
|---|---|---|---|---|
| Multi-platform laser | Z12011019 |
2 others
|
IIb MDR, 93/42 | EUDAMED record Report an error |
| Laser surgery instruments - hardware accessories | Z12011080 |
|
IIb MDR | EUDAMED record Report an error |
| Magnetotherapy equipment | Z120606 |
|
IIa MDR | EUDAMED record Report an error |
| Diode surgical laser No model still on the market | Z12011016 |
|
IIb MDR | EUDAMED record Report an error |
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