FOTONA d.o.o.

US Last updated 23 Oct 2026

Devices: 26
Registries: GUDIDEUDAMEDFDA 510(k)FDA
FDA recalls: 0

Catalogue26

Lightwalker ST-E M002-6A/2 Ref M002-6A/2

Class II FDA UDI
Fotona XP Focus M001-14F Ref M001-14F

Class II FDA UDI
Lightwalker ST-E ADVANCED M002-6A/2 ADVANCED Ref M002-6A/2 ADVANCED

Class II FDA UDI
LightWalker Max M021-5AF/1 Max Ref M021-5AF/1 Max

Class II EUDAMEDFDA UDI Active
Fotona XP Max M001-12F Ref M001-12F

Class II FDA UDI
Fotona QX Max M031-3A/2 Ref M031-3A/2

Class II FDA UDI
Fotona XP Focus M001-14F 1 Ref M001-14F 1

Class II FDA UDI
XP Spectro M001-12F Ref M001-12F

Class II FDA UDI
Lightwalker DT STAND M021-5AF/2 STAND Ref M021-5AF/2 STAND

Class II FDA UDI
AvalancheLase M071-2F/XP Ref M071-2F/XP

Class II EUDAMEDFDA UDI Active
Lightwalker DT ADVANCED M021-5AF/2 ADVANCED Ref M021-5AF/2 ADVANCED

Class II FDA UDI
Fotona XP-2 Focus M001-14F 2 Ref M001-14F 2

Class II FDA UDI
QuantumStar, StarFormer M008-3T Ref M008-3T

Class II FDA UDI Active
Lightwalker DT M021-5AF/2 Ref M021-5AF/2

Class II FDA UDI
Lightwalker ST-E STAND M002-6A/2 STAND Ref M002-6A/2 STAND

Class II FDA UDI
Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm) Ref K221712

Class II FDA 510(k) Active
LightWalker Laser System Family Ref K193661

Class II FDA 510(k) Active
Fotona XPulse Pro Laser Platform Ref K202991

Class II FDA 510(k) Active
LightWalker Laser System Family Ref K202985

Class II FDA 510(k) Active
LightWalker Laser System Family Ref K191554

Class II FDA 510(k) Active
LightWalker Laser System Family Ref K242202

Class II FDA 510(k) Active
XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro Ref K182088

Class II FDA 510(k) Active
StarFormer, TightWave Ref K221274

Class II FDA 510(k) Active
LightWalker Laser System Family Ref K172819

Class II FDA 510(k) Active
Dynamis Pro Family Ref K213267

Class II FDA 510(k) Active
AvalancheLase Family Ref K223540

Class II FDA 510(k) Active

FDA establishments1

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

Fotona D.O.O. LJUBLJANA · SI FEI 1000597018

Information

Country: US
DUNS number: 644720625

Catalogue26

Lightwalker ST-E M002-6A/2 Ref M002-6A/2

Fotona XP Focus M001-14F Ref M001-14F

Lightwalker ST-E ADVANCED M002-6A/2 ADVANCED Ref M002-6A/2 ADVANCED

LightWalker Max M021-5AF/1 Max Ref M021-5AF/1 Max

Fotona XP Max M001-12F Ref M001-12F

Fotona QX Max M031-3A/2 Ref M031-3A/2

Fotona XP Focus M001-14F 1 Ref M001-14F 1

XP Spectro M001-12F Ref M001-12F

Lightwalker DT STAND M021-5AF/2 STAND Ref M021-5AF/2 STAND

AvalancheLase M071-2F/XP Ref M071-2F/XP

Lightwalker DT ADVANCED M021-5AF/2 ADVANCED Ref M021-5AF/2 ADVANCED

Fotona XP-2 Focus M001-14F 2 Ref M001-14F 2

QuantumStar, StarFormer M008-3T Ref M008-3T

Lightwalker DT M021-5AF/2 Ref M021-5AF/2

Lightwalker ST-E STAND M002-6A/2 STAND Ref M002-6A/2 STAND

Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm) Ref K221712

LightWalker Laser System Family Ref K193661

Fotona XPulse Pro Laser Platform Ref K202991

LightWalker Laser System Family Ref K202985

LightWalker Laser System Family Ref K191554

LightWalker Laser System Family Ref K242202

XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro Ref K182088

StarFormer, TightWave Ref K221274

LightWalker Laser System Family Ref K172819

Dynamis Pro Family Ref K213267

AvalancheLase Family Ref K223540

FDA establishments1

Information