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FLUOPTICS

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30110922643011092264FLUOPTICS SAS1N2026-01-0144 rue des berges GRENOBLE Auvergne-Rhone-Alpes FR 38000
30116731303011673130FLUOPTICS IMAGING INC1Y2020-04-25185 Alewife Brook Parkway #210 Cambridge MA US 02138

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1743901252539776K250455FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM)QDG2025-04-17
1743901857959994K233564FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR)QDG2023-12-15
1743901985855618K190891Fluobeam LXQDG2019-07-31
2378411985855618K190891Fluobeam LXQDG2019-07-31
1743901346222507K132475FLUOBEAM 800 CLINIC LASER IMAGING DEVICE AND FLUOCASE 800 CONTROL SYSTEMOWN2014-05-07
2378411346222507K132475FLUOBEAM 800 CLINIC LASER IMAGING DEVICE AND FLUOCASE 800 CONTROL SYSTEMOWN2014-05-07
2378411560840911
2378411754952165
1743901824148222
2378411824148222
1743901560840911
1743901754952165

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QDG42025-04-17
OWN22014-05-07

PMN#

GUDID#