Thermidas IR System (ThIR-A615)
Thermidas Americas, Inc.
Thermi
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3017980218 | 3017980218 | THERMIDAS AMERICAS, INC. | 1 | Y | 2026-01-01 | 10735 Village Club Cir N Apt 103 Saint Petersburg FL US 33716 |
| 3010266937 | 3010266937 | ThermiGen, LLC | 1 | Y | 2020-04-25 | 3131 West Royal Lane, Suite 100 Irving TX US 75063 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 159791 | 1965168819 | K173582 | ThermiX Temperature Control Radiofrequency System, Accessories - RF Electrodes | GEI | 2018-01-17 |
| 159791 | 1349751276 | K171094 | Thermi Reusable Non-invasive RF Electrode | GEI | 2017-05-08 |
| 159791 | 2066276518 | K170116 | Thermi Injectable RF Electrodes | GEI | 2017-03-13 |
| 159791 | 1642788378 | K161661 | Thermi RF Accessories | GEI | 2016-08-12 |
| 159791 | 2026618419 | K130689 | SYMPHONY RF GENERATOR | GEI | 2013-11-15 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| GEI | 5 | 2018-01-17 |
PMN#
ThermiX Temperature Control Radiofrequency System, Accessories - RF Electrodes
ThermiGen, L.L.C
Thermi Injectable RF Electrodes
Thermi
Thermi RF Accessories
THERMI
SYMPHONY RF GENERATOR
THERMIGEN, INC.
DYNA T-2000 PHYSICAL THERAPY SYSTEM
THERMIA, INC.
HOT OR COLD PACK (THERMIPAQ)
THERMIONICS CORP.
THERMIX INC. NASOTHERM II PERSONAL STEAM MACHINE
THERMIX, INC.
GUDID#
ThermiRF+ - Thermi radio frequency generator
2022-09-05
ARVATI - Temperature Control Radiofrequency Generator
2021-09-22
ThermiRF - Thermi Radio Frequency Generator
2016-09-23
ThermiSmooth - ThermiSmooth Radiofrequency Generator
2016-09-23
ThermiVA - ThermiVa Radiofrequency Generator
2016-09-23
ThermiEyes - ThermiEyes Radiofrequency Generator
2016-09-23
RFDE-VA - RFDE-VA Disposable Radio Frequency Electrode
2016-09-23
RF Electrode - Reusable Non-Invasive RF Electrode
2016-09-23
Thermi Classic Radiofrequency Cannula - Radiofrequency Cannula - Straight Blunt
2018-02-08
Injectable RF Electrode - Disposable Radiofrequency Cannula Electrode
2017-09-20
Injectable RF Electrode - V-15-10-18-B
2017-09-20
Injectable RF Electrode - V--20-10-16-B
2017-09-20
Injectable RF Electrode - V-5-5-20-B
2017-09-20
Injectable RF Electrodes - V-Starter
2017-09-20
RF Electrode - Reusable Non-Invasive RF Electrode
2018-02-02