Identity
- Trade Name
- EMPOWER ENVISION FDA UDI
- Generic Name
- Percutaneous radio-frequency ablation system generator FDA UDI
- Device Name
- InMode RF Pro with vTone hand piece EUDAMEDInMode RF system FDA UDI
- Model / Reference
- AG609482A EUDAMEDInMode RF PRO FDA UDI
- Description
- InMode RF system FDA UDI
Identifiers
- Catalog Number
- AG609482A FDA UDI
- Primary DI / UDI-DI
- 07290016633665 EUDAMEDFDA UDI
- Basic UDI-DI
- 7290016633EMS800V93 EUDAMED
- Direct Marketing DI
- 07290016633665 EUDAMED
- 510(k) Number
- K210492 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- U070302 PELVIC FLOOR REHABILITATION DEVICES, FUNCTIONAL ELECTROSTIMULATION, SINGLE-USE EUDAMED
- GMDN Term
- Percutaneous radio-frequency ablation system generator FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Percutaneous radio-frequency ablation system generator
Empower Envision by Inmode MD , Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Percutaneous radio-frequency ablation system generator.
- OneRF Ablation System — NEUROONE MEDICAL TECHNOLOGIES CORP. · Class II
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- ATTIVA — ITALIAN ENGINEERING SRL · Class II
- OsteoCool™ RF Ablation System — MEDTRONIC SOFAMOR DANEK, INC. · Class II
- Maestro 4000™ Controller — Boston Scientific · Class III
- SmartAblate™ System CoolFlow® Pump Cable — Stockert GmbH · Class III
- InSeal Sealer/Divider — Innolcon Medical Technology (Suzhou) Co., Ltd. · Class IIb
- Electrosurgical Pencil, Button Switch — DEROYAL INDUSTRIES, INC. · Class IIb
Cleared under the same submission
K210492 also covers:
- APEX RF System — Inmode MD , Ltd.
- ApexRF Applicator — Inmode MD , Ltd.
- CelluTite System — Inmode MD , Ltd.
- EmPowerRF platform — Inmode MD , Ltd.
- Envision System — Inmode MD , Ltd.
- FRACTORA 3D-90 Tip — Inmode MD , Ltd.
- FormaI — Inmode MD , Ltd.
- Luxora System — Inmode MD , Ltd.
- Morpheus8 TIP — Inmode MD , Ltd.
- Morpheus8C Handpiece — Inmode MD , Ltd.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Inmode MD , Ltd.
Sources (2)
- FDA UDI a7e5ed4e-c7e6-4abe-846a-ef05f29f8feb 36 fields · synced Jul 14, 2026
- EUDAMED 4201e291-ed5b-48a8-bf35-cfbbef6ca3ec 61 fields · synced Jul 14, 2026