Body-Jet Eco
body-jet eco device, for Water-jet Assisted Liposuction, 120 - 230 V, 50-60 Hz, 11 kg, IP 22
2manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
1recall
Who Else Makes It
Concentrated in Jiangsu (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Shun YE Medical Company, Ltd. | Cixi Ningbo | Zhejiang | Contract manufacturer | 8 |
| Jiangsu Caina Medical Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 20 |
Record
| Listed by | Human MED AG, Germany |
|---|---|
| FDA product code | QPB |
| Device type | System, Suction, Lipoplasty For Removal |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5040 |
| Establishment | Manufacturer |
| 510(k) | K082025 |
| Record published | 2025-07-30 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
| Storage | Storage environment temperature -20 to 50 °C; Storage environment humidity 10 to 95 % RH; Handling environment temperature -20 to 50 °C; Handling environment humidity 10 to 95 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| body-jet eco liposuction device, 100 – 230 V, 50-60 Hz, 11 kg | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Origins | Solta Medical, Inc. | 164 |
| MicroAire® | Microaire Surgical Instruments LLC | 156 |
| Tulip Gems™ Single-Use | Tulip Medical Products, Inc. | 53 |
| Tulip Gems™ AlphaLuer Single-Use | Tulip Medical Products, Inc. | 33 |
| Vaser | Solta Medical, Inc. | 20 |
| System, Suction, Lipoplasty For Removal | Black & Black Surgical, Inc. | 12 |
| WAL Cannula | Human MED AG | 7 |
| Biofill cannula | Human MED AG | 6 |
| WAL infiltration cannula | Human MED AG | 5 |
| Ayon Ultrasound Assisted Liposuction Probe: 3.7mm diameter, 33cm length, 5 rings | Apyx Medical Corporation | 5 |
| WAL irrigation/aspiration cannula | Human MED AG | 4 |
| Black & Black Surgical, Inc. | Black & Black Surgical, Inc. | 4 |
Showing 12 of 66. All products under System, Suction, Lipoplasty For Removal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K082025 | 2008-08-13 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Human MED AG | 510(k) number | 2024-10-18 | Class II | Process control | The cannula tubes do not comply with the specification. The water jet emerging from the nozzle of the nonconforming cannulas may emerge as a spot jet rather than a fan-shaped spray jet. | 775 devices |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.