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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