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Fotona D.D.

US

Last updated May 23, 2026

Information

Country
US
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Website
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EUDAMED SRN
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FDA FEI Number
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Catalogue (53)

Page 1 of 2
DeviceModel / ReferenceRegistriesClassStatus
Lightwalker ST-E M002-6A/2
FDA UDI
Class IIUnknown
Fotona XP Focus M001-14F
FDA UDI
Class IIUnknown
Lightwalker ST-E ADVANCED M002-6A/2 ADVANCED
FDA UDI
Class IIUnknown
LightWalker Max M021-5AF/1 Max
FDA UDI
Class IIActive
Fotona XP Max M001-12F
FDA UDI
Class IIUnknown
Fotona QX Max M031-3A/2
FDA UDI
Class IIUnknown
Fotona XP Focus M001-14F 1
FDA UDI
Class IIUnknown
XP Spectro M001-12F
FDA UDI
Class IIUnknown
Lightwalker DT STAND M021-5AF/2 STAND
FDA UDI
Class IIUnknown
AvalancheLase M071-2F/XP
FDA UDI
Class IIActive
Lightwalker DT ADVANCED M021-5AF/2 ADVANCED
FDA UDI
Class IIUnknown
Fotona XP-2 Focus M001-14F 2
FDA UDI
Class IIUnknown
QuantumStar, StarFormer M008-3T
FDA UDI
Class IIActive
Lightwalker DT M021-5AF/2
FDA UDI
Class IIUnknown
Lightwalker ST-E STAND M002-6A/2 STAND
FDA UDI
Class IIUnknown
Lightwalker At Lightwalker Dt Lightwalker St-E Lightwalker St-N K121508
FDA 510(k)
Class IIActive
Fotona Fidelis Plus Nd:yag Laser System K024204
FDA 510(k)
Class IIActive
Lightwalker At, Model M021-5af/1, Lightwalker Dt, Model M021-5af/2, Lightwalker St-E, Model M002-6a/2, Lightwalker St-N K101817
FDA 510(k)
Class IIActive
Fotona Xd-2 Diode Laser System, Model Md01-2f K083034
FDA 510(k)
Class IIActive
Fotona Tandem Laser System K022837
FDA 510(k)
Class IIActive
Fotona Novalis Er: Yag Laser System K991632
FDA 510(k)
Class IIActive
Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm) K221712
FDA 510(k)
Class IIActive
LightWalker Laser System Family K193661
FDA 510(k)
Class IIActive
Fotona XPulse Pro Laser Platform K202991
FDA 510(k)
Class IIActive
Fotona Skinplus Laser System K980560
FDA 510(k)
Class IIActive
Sp Dynamis, Sp Spectro, Xs Dynamis, Xs Spectro, Xp Dynamis, Xp Spectro, Models M021-4af/3, M002-2a K101306
FDA 510(k)
Class IIActive
Depilase Yaglase Nd:yag Laser System And Accessories K000106
FDA 510(k)
Class IIActive
Fotona F-22 Laser Handpiece (f-Runner), Fotona Fs-01 Laser Handpiece K132806
FDA 510(k)
Class IIActive
Fotona Novalis R Ruby Laser System K991634
FDA 510(k)
Class IIActive
LightWalker Laser System Family K202985
FDA 510(k)
Class IIActive
Paradigm-Fotona Yaplase Nd:yap Laser System And Accessories K002884
FDA 510(k)
Class IIActive
LightWalker Laser System Family K191554
FDA 510(k)
Class IIActive
LightWalker Laser System Family K242202
FDA 510(k)
Class IIActive
Fotona Fidelis Iii Er:yag/Nd:yag Laser System Family K070355
FDA 510(k)
Class IIActive
Fotona Dualis Nd:yag/Er:yag Laser System K021548
FDA 510(k)
Class IIActive
Paradigm-Fontona Perovskite Nd: Yap Laser System And Accessories K011174
FDA 510(k)
Class IIActive
Fidelis Plus Iii D, At Fidelis D, Powerlase At D / Fidelis Plus Iii, At Fidelis, Powerlase At / Fidelis Er Iii D, Ht Fid K093162
FDA 510(k)
Class IIActive
Fotona Qx Nd:yag/Ktp Laser System Family K083889
FDA 510(k)
Class IIActive
Fotona Dualis Plus Nd:yag Laser System K022839
FDA 510(k)
Class IIActive
Fotona Fidelis Er: Yag Laser System And Accesories K001527
FDA 510(k)
Class IIActive
SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro K143723
FDA 510(k)
Class IIActive
Fotona Xp Nd: Yag Laser System K113702
FDA 510(k)
Class IIActive
Fotona Xp Plus Nd: Yag Family Of Laser Systems, Fontona Dualis Xp Plus Nd: Yag Family Of Laser Systems K050293
FDA 510(k)
Class IIActive
Fotona Dualis Er:yag/Ktp Laser System K022838
FDA 510(k)
Class IIActive
XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro K182088
FDA 510(k)
Class IIActive
Fotona Dualis, Fotona Dualis Plus K011939
FDA 510(k)
Class IIActive
Fotona Xp Nd: Yag Laser System Family, Fotona Xp, Xp-2 Focus, Fotona Xp Changer, Model Moo1-14f, Moo1-14f, Moo1-14f/2, K090126
FDA 510(k)
Class IIActive
StarFormer, TightWave K221274
FDA 510(k)
Class IIActive
LightWalker Laser System Family K172819
FDA 510(k)
Class IIActive
Dynamis Pro Family K213267
FDA 510(k)
Class IIActive

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

  • Fotona D.o.o. LJUBLJANA · SI FEI 1000597018