ThermiGen, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30102669373010266937ThermiGen, LLC1Y2020-04-253131 West Royal Lane, Suite 100 Irving TX US 75063

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1597911965168819K173582ThermiX Temperature Control Radiofrequency System, Accessories - RF ElectrodesGEI2018-01-17
1597911349751276K171094Thermi Reusable Non-invasive RF ElectrodeGEI2017-05-08
1597912066276518K170116Thermi Injectable RF ElectrodesGEI2017-03-13
1597911642788378K161661Thermi RF AccessoriesGEI2016-08-12
1597912026618419K130689SYMPHONY RF GENERATORGEI2013-11-15

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEI52018-01-17

PMN#