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Fotona D.D.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
43
Inspections
3
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K241785StarFormer (M008-3T)March 27, 2025
K242202LightWalker Laser System FamilyAugust 23, 2024
K234061StarFormerJuly 1, 2024
K221274StarFormer, TightWaveSeptember 29, 2023
K223540AvalancheLase FamilyJanuary 19, 2023
K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)October 12, 2022
K213267Dynamis Pro FamilySeptember 8, 2022
K202991Fotona XPulse Pro Laser PlatformJune 22, 2021
K202985LightWalker Laser System FamilyMarch 19, 2021
K202172StarWalkerNovember 19, 2020
K193656SkyPulseMarch 27, 2020
K193661LightWalker Laser System FamilyMarch 25, 2020
K191554LightWalker Laser System FamilyAugust 30, 2019
K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroOctober 31, 2018
K172819LightWalker Laser System FamilyDecember 1, 2017
K171227StarWalkerAugust 18, 2017
K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroApril 9, 2015
K132806FOTONA F-22 LASER HANDPIECE (F-RUNNER), FOTONA FS-01 LASER HANDPIECEJuly 11, 2014
K121508LIGHTWALKER AT LIGHTWALKER DT LIGHTWALKER ST-E LIGHTWALKER ST-NDecember 12, 2012
K113702FOTONA XP ND: YAG LASER SYSTEMMarch 28, 2012