Identity
- Trade Name
- InMode RF hand piece FDA UDI
- Generic Name
- Radio-frequency fat liquefaction system FDA UDI
- Device Name
- AccuTite FDA UDI
- Model / Reference
- HP060909A FDA UDI
- Description
- AccuTite FDA UDI
Identifiers
- Catalog Number
- HP060909A FDA UDI
- Primary DI / UDI-DI
- 07290016633481 FDA UDI
- 510(k) Number
- K182325 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
- 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
Category: Radio-frequency fat liquefaction system
InMode RF hand piece by Inmode MD , Ltd. — Class II — FDA UDI — listed in FDA GUDID — 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
- InMode RF hand piece — Inmode MD , Ltd. · Class II
- InModeRF hand piece — Inmode MD , Ltd. · Class II
Cleared under the same submission
K182325 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Inmode MD , Ltd.
Sources (1)
- FDA UDI b94ace0d-b0cb-4140-94d6-fb5e3756f18c 37 fields · synced May 30, 2026