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FDA 510(k) Applications Submitted by Fotona d.o.o.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K202172
08/03/2020
StarWalker
Fotona d.o.o.
K191554
06/12/2019
LightWalker Laser System Family
Fotona d.o.o.
K221712
06/13/2022
Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)
Fotona d.o.o.
K182088
08/02/2018
XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro
Fotona d.o.o.
K172819
09/18/2017
LightWalker Laser System Family
Fotona d.o.o.
K202991
09/30/2020
Fotona XPulse Pro Laser Platform
Fotona d.o.o.
K213267
09/30/2021
Dynamis Pro Family
Fotona d.o.o.
K193656
12/30/2019
SkyPulse
Fotona d.o.o.
K193661
12/30/2019
LightWalker Laser System Family
Fotona d.o.o.
K202985
09/30/2020
LightWalker Laser System Family
Fotona d.o.o.
K171227
04/26/2017
StarWalker
Fotona d.o.o.
K221274
05/02/2022
StarFormer, TightWave
Fotona d.o.o.
K223540
11/25/2022
AvalancheLase Family
Fotona d.o.o.
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