Identity
- Trade Name
- Contoura - InMode RF™ FDA UDI
- Generic Name
- Percutaneous radio-frequency ablation system generator FDA UDI
- Device Name
- Contoura (InModeRF Color 3, Contura, Black-Blue) FDA UDI
- Model / Reference
- InMode RF™ - Black-Blue FDA UDI
- Description
- Contoura (InModeRF Color 3, Contura, Black-Blue) FDA UDI
Identifiers
- Catalog Number
- AG606970A FDA UDI
- Primary DI / UDI-DI
- 07290016633344 FDA UDI
- 510(k) Number
- K131362 FDA UDIK140926 FDA UDIK151273 FDA UDIK151793 FDA UDIK160329 FDA UDIK172302 FDA UDIK180189 FDA UDI
- FDA Product Code
- GEI FDA UDIPBX FDA UDI
- GMDN Term
- Percutaneous radio-frequency ablation system generator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Percutaneous radio-frequency ablation system generator
Contoura - InMode RF™ by Inmode MD , Ltd. — Class II — FDA UDI — listed in FDA GUDID — 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
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- Maestro 4000™ Controller — Boston Scientific · Class III
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- InSeal Sealer/Divider — Innolcon Medical Technology (Suzhou) Co., Ltd. · Class IIb
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Cleared under the same submission
K131362 also covers:
K140926 also covers:
K151273 also covers:
K151793 also covers:
K160329 also covers:
K172302 also covers:
K180189 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Inmode MD , Ltd.
Sources (1)
- FDA UDI 26d41e7f-b3a3-416b-8ca2-e2fc9b3f31f8 37 fields · synced May 31, 2026