Vaser
ACC. KIT, Mangubat, Traditional
2manufacturers in China registered for this device type
20catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Solta Medical, Inc., United States |
|---|---|
| FDA product code | QPB |
| Device type | System, Suction, Lipoplasty For Removal |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5040 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2022-04-07 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 130-0563 | In distribution | |
| 130-0097 | In distribution | |
| 115-0029 | In distribution | |
| 115-0004 | In distribution | |
| P010338-03 | In distribution | |
| 115-0021 | In distribution | |
| 130-0118 | In distribution | |
| 115-0024 | In distribution | |
| 130-0524 | In distribution | |
| 115-0019 | In distribution | |
| 115-0022 | In distribution | |
| 130-0525 | In distribution | |
| 130-0119 | In distribution | |
| 130-0095 | In distribution | |
| 130-0171 | In distribution | |
| 115-0043 | In distribution | |
| 130-0562 | In distribution | |
| 115-0025 | In distribution | |
| 115-0020 | In distribution | |
| 130-0526 | 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 |
| 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 |
| Powerx | Solta Medical, Inc. | 3 |
Showing 12 of 66. All products under System, Suction, Lipoplasty For Removal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K190551 | 2019-05-01 |
| K190555 | 2019-05-01 |
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.