Product areas
FDA product code distribution
Fotona D.O.O.
Country / region:Slovenia (SI)
510(k) submissions
13
Filtered: GEX
Latest clearance
2024-08-23
Product codes
1
GEX
510(k) submissions
13 total · filtered by GEX
| K number | Device name | Product code | Class | Decision date |
|---|---|---|---|---|
| K242202 | LightWalker Laser System Family | GEX | Class 2 | 2024-08-23 |
| K223540 | AvalancheLase Family | GEX | Class 2 | 2023-01-19 |
| K221712 | Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm) | GEX | Class 2 | 2022-10-12 |
| K213267 | Dynamis Pro Family | GEX | Class 2 | 2022-09-08 |
| K202991 | Fotona XPulse Pro Laser Platform | GEX | Class 2 | 2021-06-22 |
| K202985 | LightWalker Laser System Family | GEX | Class 2 | 2021-03-19 |
| K202172 | StarWalker | GEX | Class 2 | 2020-11-19 |
| K193656 | SkyPulse | GEX | Class 2 | 2020-03-27 |
| K193661 | LightWalker Laser System Family | GEX | Class 2 | 2020-03-25 |
| K191554 | LightWalker Laser System Family | GEX | Class 2 | 2019-08-30 |
| K182088 | XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro | GEX | Class 2 | 2018-10-31 |
| K172819 | LightWalker Laser System Family | GEX | Class 2 | 2017-12-01 |
| K171227 | StarWalker | GEX | Class 2 | 2017-08-18 |
Company profile
- Canonical name
- Fotona D.O.O.
- Country
- Slovenia(SI)
- Address
- Stegne 7 Ljubljana, SI SI-1000
Cited predicates
49- K202985
LightWalker Laser System Family
- K140732
—
—
Not ingested - K153671
Family of CoolGlide Aesthetic Lasers
- K162886
DEKA MOTUS AX
- K201111
GentleMax Pro Plus
- K213267
Dynamis Pro Family
- K193656
SkyPulse
- K202985
LightWalker Laser System Family
- K202991
Fotona XPulse Pro Laser Platform
- K182088
XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro
- K202985
LightWalker Laser System Family
- K083034
—
—
Not ingested - K193656
SkyPulse
- K192272
Wolf445nm
- K180044
SIROLaser Blue
- K073322
—
—
Not ingested - K193661
LightWalker Laser System Family
- K182088
XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro
- K191685
PicoWay Laser System
- K173199
PicoSure Workstation
- K171227
StarWalker
- K113588
—
—
Not ingested - K083889
—
—
Not ingested - K011939
—
—
Not ingested - K191554
LightWalker Laser System Family
- K190319
Waterlase Laser System Family
- K182088
XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro
- K152722
neoV980 & neoV1470 Diode Lasers
- K191554
LightWalker Laser System Family
- K182088
XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro
- K073322
—
—
Not ingested - K082707
—
—
Not ingested - K083034
—
—
Not ingested - K083069
—
—
Not ingested - K101916
—
—
Not ingested - K133006
—
—
Not ingested - K152939
Picasso Plus, Picasso Lite Plus
- K163128
Epic Pro
- K170500
SIROLaser Advance+
- K190319
Waterlase Laser System Family
- K141861
—
—
Not ingested - K172819
LightWalker Laser System Family
- K143723
SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro
- K070355
—
—
Not ingested - K121508
—
—
Not ingested - K151763
PerioLase Nd:YAG Pulsed Dental Laser System
- K011939
—
—
Not ingested - K083889
—
—
Not ingested - K143723
SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro
Fotona D.O.O. references 49 predicate/reference devices
Cited as predicate
25- K253344
BELLUS-Q
- K253342
PICO-K
- K242202
LightWalker Laser System Family
- K241791
Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D)
- K240179
Medical Diode Laser (Model: L2)
- K234004
Medical diode laser systems (CHARISMA, REGAL)
- K230274
Medical Diode Laser (M2)
- K223540
AvalancheLase Family
- K221712
Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)
- K221712
Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)
- K221712
Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)
- K220531
FOX 810, FOX 980
- K213350
mJOULE System and Accessories
- K213267
Dynamis Pro Family
- K213267
Dynamis Pro Family
- K202991
Fotona XPulse Pro Laser Platform
- K202985
LightWalker Laser System Family
- K202985
LightWalker Laser System Family
- K202288
Finebeam
- K202172
StarWalker
- K193661
LightWalker Laser System Family
- K193661
LightWalker Laser System Family
- K193656
SkyPulse
- K193656
SkyPulse
- K191554
LightWalker Laser System Family
25 submissions cite Fotona D.O.O. as a predicate