BEUDAMED
    81 results · 66ms · Sources: EU EUDAMED, US FDA

    LightWalker Laser System Family

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Dynamis Pro Family

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    StarWalker

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Fotona XPulse Pro Laser Platform

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    LightWalker Laser System Family

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SP Dynamis

    Device
    EU MDD · Eu Md Class 2b ·FOTONA, proizvodnja optoelektronskih naprav d.o.o.·On the market·32 countries

    XPulse

    Device
    EU MDR · Eu Md Class 2b ·FOTONA, proizvodnja optoelektronskih naprav d.o.o.·No longer on the market·32 countries

    SP Dynamis

    Device
    EU MDR · Eu Md Class 2b ·FOTONA, proizvodnja optoelektronskih naprav d.o.o.·On the market·32 countries

    StarWalker

    Device
    EU MDR · Eu Md Class 2b ·FOTONA, proizvodnja optoelektronskih naprav d.o.o.·On the market·32 countries

    StarWalker

    Device
    EU MDR · Eu Md Class 2b ·FOTONA, proizvodnja optoelektronskih naprav d.o.o.·On the market·32 countries

    StarWalker

    Device
    EU MDR · Eu Md Class 2b ·FOTONA, proizvodnja optoelektronskih naprav d.o.o.·On the market·32 countries

    AvalancheLase

    Device
    EU MDR · Eu Md Class 2b ·FOTONA, proizvodnja optoelektronskih naprav d.o.o.·On the market·32 countries

    StarFormer

    Device
    EU MDR · Eu Md Class 2a ·FOTONA, proizvodnja optoelektronskih naprav d.o.o.·On the market·32 countries

    XPulse Family

    Basic UDI-DI
    EU MDR · Eu Md Class 2b ·FOTONA, proizvodnja optoelektronskih naprav d.o.o.·1 device

    Dynamis Spectro Family

    Basic UDI-DI
    EU MDR · Eu Md Class 2b ·FOTONA, proizvodnja optoelektronskih naprav d.o.o.·1 device

    SP Dynamis

    Basic UDI-DI
    EU MDD · Eu Md Class 2b ·FOTONA, proizvodnja optoelektronskih naprav d.o.o.·1 device

    StarFormer IntimaWave Family

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·FOTONA, proizvodnja optoelektronskih naprav d.o.o.·1 device

    StarWalker Family

    Basic UDI-DI
    EU MDR · Eu Md Class 2b ·FOTONA, proizvodnja optoelektronskih naprav d.o.o.·3 devices

    AvalancheLase Family

    Basic UDI-DI
    EU MDR · Eu Md Class 2b ·FOTONA, proizvodnja optoelektronskih naprav d.o.o.·1 device

    2022-MDR/QS-021

    Certificate
    MDR QMS·FOTONA, proizvodnja optoelektronskih naprav d.o.o.·3EC International a.s.