Fotona D.O.O. - FDA 510(k) Cleared Devices
16
Total
16
Cleared
0
Denied
Fotona D.O.O. has 16 FDA 510(k) cleared general & plastic surgery devices. Based in Ljubljana, SI.
Latest FDA clearance: Mar 2025. Active since 2017.
Browse the complete list of FDA 510(k) cleared general & plastic surgery devices from this manufacturer. Filter by specialty or product code using the sidebar.
16 devices
Cleared
Mar 27, 2025
StarFormer (M008-3T)
Physical Medicine
280d
Cleared
Aug 23, 2024
LightWalker Laser System Family
General & Plastic Surgery
28d
Cleared
Jul 01, 2024
StarFormer
Gastroenterology & Urology
192d
Cleared
Sep 29, 2023
StarFormer, TightWave
Physical Medicine
515d
Cleared
Jan 19, 2023
AvalancheLase Family
General & Plastic Surgery
55d
Cleared
Oct 12, 2022
Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)
General & Plastic Surgery
121d
Cleared
Sep 08, 2022
Dynamis Pro Family
General & Plastic Surgery
343d
Cleared
Jun 22, 2021
Fotona XPulse Pro Laser Platform
General & Plastic Surgery
265d
Cleared
Mar 19, 2021
LightWalker Laser System Family
General & Plastic Surgery
170d
Cleared
Nov 19, 2020
StarWalker
General & Plastic Surgery
108d
Cleared
Mar 27, 2020
SkyPulse
General & Plastic Surgery
88d
Cleared
Mar 25, 2020
LightWalker Laser System Family
General & Plastic Surgery
86d
Cleared
Aug 30, 2019
LightWalker Laser System Family
General & Plastic Surgery
79d
Cleared
Oct 31, 2018
XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro
General & Plastic Surgery
90d
Cleared
Dec 01, 2017
LightWalker Laser System Family
General & Plastic Surgery
74d
Cleared
Aug 18, 2017
StarWalker
General & Plastic Surgery
114d