Identity
- Trade Name
- InMode RF hand piece FDA UDI
- Generic Name
- Radio-frequency fat liquefaction system FDA UDI
- Device Name
- Handpiece comprises internal active electrode, external return electrode, both with temperature sensor, handle, cable and connector. Handpiece HP253966A has an active electrode diameter of 3.3mm and return electrode of 24mm diameter and 25cm long. Maximal RF power 60W. FDA UDI
- Model / Reference
- HP253966A FDA UDI
- Description
- Handpiece comprises internal active electrode, external return electrode, both with temperature sensor, handle, cable and connector. Handpiece HP253966A has an active electrode diameter of 3.3mm and return electrode of 24mm diameter and 25cm long. Maximal RF power 60W. FDA UDI
Identifiers
- Catalog Number
- HP253966A FDA UDI
- Primary DI / UDI-DI
- 07290019863052 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Radio-frequency fat liquefaction system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
InMode RF hand piece by Inmode MD , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K233642 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 5e6784c3-b669-4c17-ba68-707118e74a5a 38 fields · synced May 30, 2026