FOTONA D.O.O.

Matched from indexed company URL: FOTONA d.o.o.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96134621000597018FOTONA D.O.O.1N2026-01-01STEGNE 7, LJUBLJANA SI 1000

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
175961645531720K242202LightWalker Laser System FamilyGEX2024-08-23
175961165424722K241785StarFormer (M008-3T)QPL2025-03-27
175961177190264K234061StarFormerKPI2024-07-01
175961685822255K223540AvalancheLase FamilyGEX2023-01-19
175961675208159K221274StarFormer, TightWaveIPF2023-09-29
175961636719453K213267Dynamis Pro FamilyGEX2022-09-08
175961206421465K202985LightWalker Laser System FamilyGEX2021-03-19
175961187286900K202172StarWalkerGEX2020-11-19
175962047951045K193661LightWalker Laser System FamilyGEX2020-03-25
175961688799327K193656SkyPulseGEX2020-03-27
175961670676775K191554LightWalker Laser System FamilyGEX2019-08-30
175961248359248K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroGEX2018-10-31
175961279768641K172819LightWalker Laser System FamilyGEX2017-12-01
175961663010503K171227StarWalkerGEX2017-08-18
175961972379930K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroGEX2015-04-09
175961437699859K113702FOTONA XP ND: YAG LASER SYSTEMPDZ2012-03-28
175961739605108K090126FOTONA XP ND: YAG LASER SYSTEM FAMILY, FOTONA XP, XP-2 FOCUS, FOTONA XP CHANGER,MODEL MOO1-14F, MOO1-14F, MOO1-14F/2,GEX2009-06-29
175961530648990K050293FOTONA XP PLUS ND: YAG FAMILY OF LASER SYSTEMS, FONTONA DUALIS XP PLUS ND: YAG FAMILY OF LASER SYSTEMSGEX2005-03-18

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEX142024-08-23
QPL12025-03-27
KPI12024-07-01
IPF12023-09-29
PDZ12012-03-28

PMN#

GUDID#

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