Fotona D.O.O. - FDA 510(k) Cleared Devices

Cleared Aug 23, 2024

LightWalker Laser System Family

K242202 · GEX

General & Plastic Surgery · 28d

Cleared Jan 19, 2023

AvalancheLase Family

K223540 · GEX

General & Plastic Surgery · 55d

Cleared Oct 12, 2022

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

K221712 · GEX

General & Plastic Surgery · 121d

Cleared Sep 08, 2022

Dynamis Pro Family

K213267 · GEX

General & Plastic Surgery · 343d

Cleared Jun 22, 2021

Fotona XPulse Pro Laser Platform

K202991 · GEX

General & Plastic Surgery · 265d

Cleared Mar 19, 2021

LightWalker Laser System Family

K202985 · GEX

General & Plastic Surgery · 170d

Cleared Nov 19, 2020

StarWalker

K202172 · GEX

General & Plastic Surgery · 108d

Cleared Mar 27, 2020

SkyPulse

K193656 · GEX

General & Plastic Surgery · 88d

Cleared Mar 25, 2020

LightWalker Laser System Family

K193661 · GEX

General & Plastic Surgery · 86d

Cleared Aug 30, 2019

LightWalker Laser System Family

K191554 · GEX

General & Plastic Surgery · 79d

Cleared Oct 31, 2018

XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro

K182088 · GEX

General & Plastic Surgery · 90d

Cleared Dec 01, 2017

LightWalker Laser System Family

K172819 · GEX

General & Plastic Surgery · 74d