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US
Last updated May 23, 2026
What Thermi makes
Thermi manufactures single-use monopolar electrosurgical electrodes for open surgery, as well as percutaneous radio-frequency ablation systems designed for tissue treatment. Their portfolio includes medium-wave diathermy electrodes and injectable radio-frequency electrodes, alongside devices like the ThermiRF+ and ThermiSmooth for targeted thermal ablation procedures. These products are used in procedures requiring controlled tissue modification, such as cosmetic or functional treatments.
Thermi’s devices fall under FDA Class II regulation, with many authorised through the 510(k) pathway and listed under the FDA’s Unique Device Identifier (UDI) system. The company’s products are primarily intended for the US market, adhering to regulatory requirements for radio-frequency and electrosurgical instruments. No additional international regulatory listings are specified.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 021008486
Catalogue (17)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Arvati | ARVATI | FDA UDI | Class II | Active |
| ThermiRF+ | ThermiRF+ | FDA UDI | Class II | Active |
| Injectable RF Electrodes | V-Starter | FDA UDI | Class II | Active |
| RF Electrode | RFE-15-D | FDA UDI | Class II | Active |
| Injectable RF Electrode | V-5-5-20-B | FDA UDI | Class II | Active |
| ThermiSmooth | ThermiSmooth 20 | FDA UDI | Class II | Active |
| ThermiVA | ThermiVa | FDA UDI | Class II | Active |
| RF Electrode | RFE-10-D | FDA UDI | Class II | Active |
| Thermi Classic Radiofrequency Cannula | S-505-B-20 | FDA UDI | Class II | Active |
| Injectable RF Electrode | V--20-10-16-B | FDA UDI | Class II | Active |
| Rfde-Va | RFDE-VA | FDA UDI | Class II | Active |
| Injectable RF Electrode | V-10-10-18-B | FDA UDI | Class II | Active |
| Injectable RF Electrode | V-15-10-18-B | FDA UDI | Class II | Active |
| ThermiRF | ThermiRF | FDA UDI | Class II | Active |
| ThermiEyes | ThermiEyes | FDA UDI | Class II | Active |
| Thermi RF Accessories | K161661 | FDA 510(k) | Class II | Active |
| Thermi Injectable RF Electrodes | K170116 | FDA 510(k) | Class II | Active |
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