Identity
- Trade Name
- InMode RF hand piece FDA UDI
- Generic Name
- Radio-frequency fat liquefaction system FDA UDI
- Device Name
- Hand piece HP101396A EUDAMEDFaceTite 2-Pack black FDA UDI
- Model / Reference
- HP101396A EUDAMEDFDA UDI
- Description
- FaceTite 2-Pack black FDA UDI
Identifiers
- Catalog Number
- HP101396A FDA UDI
- Primary DI / UDI-DI
- 07290019863281 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07290019863281 EUDAMED
- 510(k) Number
- K240780 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- Z12040214 LIPOSUCTION SYSTEMS EUDAMED
- GMDN Term
- Radio-frequency fat liquefaction system FDA UDI
Classification
- Device Class
- Class IIb 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
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Category: Radio-frequency fat liquefaction system
InMode RF hand piece by Inmode MD , Ltd. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Radio-frequency fat liquefaction system.
- InMode RF hand piece — Inmode MD , Ltd. · Class II
- InMode RF hand piece — Inmode MD , Ltd. · Class II
- InModeRF hand piece — Inmode MD , Ltd. · Class II
- InMode RF hand piece — Inmode MD , Ltd. · Class II
- InMode RF hand piece — Inmode MD , Ltd. · Class II
- InModeRF hand piece — Inmode MD , Ltd. · Class II
- InMode RF hand piece — Inmode MD , Ltd. · Class II
Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Inmode MD , Ltd.
Sources (2)
- FDA UDI 9d4f1eb3-289c-467b-9614-50c8f7b56b2d 37 fields · synced Jun 19, 2026
- EUDAMED 1abc8b8e-c03e-4736-ba71-a966059100a7 61 fields · synced Jun 19, 2026