Identity
- Trade Name
- body-jet evo FDA UDI
- Generic Name
- Liposuction system FDA UDI
- Device Name
- body-jet evo device, for Water-jet Assisted Liposuction, 120 V, 60 Hz, 6A, 65 kg, IP 22 FDA UDI
- Model / Reference
- body-jet evo liposuction device, 120 V, 60 Hz, 65 kg FDA UDI
- Description
- body-jet evo device, for Water-jet Assisted Liposuction, 120 V, 60 Hz, 6A, 65 kg, IP 22 FDA UDI
Identifiers
- Catalog Number
- 500000-17 FDA UDI
- Primary DI / UDI-DI
- 04260170881328 FDA UDI
- 510(k) Number
- K082025 FDA UDI
- FDA Product Code
- QPB FDA UDI
- GMDN Term
- Liposuction system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.5040 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Liposuction system
body-jet evo by Human Med AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Liposuction system.
- ORIGINS — Solta Medical, Inc. · Class II
- MicroAire® — MicroAire Surgical Instruments LLC · Class II
- AYON Base Tower — Apyx Medical Corporation · Class II
- MicroAire® — MicroAire Surgical Instruments LLC · Class II
- ORIGINS — Solta Medical, Inc. · Class II
- Alma LipoFlow System 50Hz — ALMA LASERS LTD. · Class II
- AirSculpt Handpiece — Millennium Medical Technologies, Inc. · Class II
- SUMMIT MEDICAL — Summit Medical, LLC · Class II
Cleared under the same submission
K082025 also covers:
- Biofill Cannula — Human Med AG
- Biofill Cannula — Human Med AG
- Biofill Cannula — Human Med AG
- Biofill Infiltration Cannula — Human Med AG
- Biofill applicator — Human Med AG
- Biofill cannula — Human Med AG
- Biofill cannula — Human Med AG
- Biofill cannula — Human Med AG
- Biofill cannula, RAPID — Human Med AG
- Biofill infiltration cannula — Human Med AG
- Hydrophobic Filter-set — Human Med AG
- Hydrophobic Filter-set — Human Med AG
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
- Human Med AG
Sources (1)
- FDA UDI dca0cb2d-19ed-4534-a7a3-9637a76734d7 37 fields · synced Jun 6, 2026