FDA.reportPublic FDA data

VASER

Primary DI
00816995021612
Brand
VASER
Company
SOLTA MEDICAL
Model
115-0043
Catalog number
115-0043
Device description
ACCESSORY KIT, FAT GRAFTING
Published
2022-04-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
QPBSystem, Suction, Lipoplasty For Removal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QPBSystem, Suction, Lipoplasty For RemovalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816995021612PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816995021612008169950216128169950216120816995021612

GMDN Terms#

Term, Definition table
TermDefinition
Liposuction systemAn assembly of devices designed specifically to aspirate subcutaneous fat from the body by means of suction during a liposuction/lipectomy procedure. The system consists of an electrically-powered suction pump, typically with collection containers, tubing, and microbial/hydrophobic filters, and includes patient contact devices (e.g., handpiece/tip, cannula). The pump generates negative pressure for aspiration of fat through the patient contact device, which is inserted subcutaneously into the fat layer, and into the collection containers.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
079999584
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816995027775Fraxel FTXMC15MM12MC15MM122025-04-02
00816995027782Fraxel FTXMC7MM12MC7MM122025-04-02
00816995027799Fraxel FTXMCSYSFTX-RMCSYSFTX-R2025-04-02
00816995027805Fraxel FTXMCSYSFTXMCSYSFTX2025-04-02
00816995021513VASERP010338-03P010338-032022-04-08
00816995022633ORIGINS810-MCBT5033PXNR810-MCBT5033PXNR2022-04-08
00816995022664ORIGINS810-MCBU3020LLNR810-MCBU3020LLNR2022-04-08
00816995022718ORIGINS810-MCBU3030VXNR810-MCBU3030VXNR2022-04-08
00816995022787ORIGINS810-MCBU4030PXNR810-MCBU4030PXNR2022-04-08
00816995022800ORIGINS810-MCBU4030VXNR810-MCBU4030VXNR2022-04-08
00816995022879ORIGINS810-MCBU5030PXNR810-MCBU5030PXNR2022-04-08
00816995022893ORIGINS810-MCBU5030VXNR810-MCBU5030VXNR2022-04-08
00816995022916ORIGINS810-MDMD3030PXNR810-MDMD3030PXNR2022-04-08
00816995022947ORIGINS810-MDMD4030PXNR810-MDMD4030PXNR2022-04-08
00816995022978ORIGINS810-MDMD5030PXNR810-MDMD5030PXNR2022-04-08
00816995023005ORIGINS810-MDMD6030PXNR810-MDMD6030PXNR2022-04-08
00816995023050ORIGINS810-SGBU4030PXNR810-SGBU4030PXNR2022-04-08
00816995023173ORIGINS810-SLBU4026PXNR810-SLBU4026PXNR2022-04-08
00816995023418ORIGINS810-SPSP4033VXNR810-SPSP4033VXNR2022-04-08
00816995023500ORIGINS810-STBT3026BDCX810-STBT3026BDCX2022-04-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03701416200035EUROMIEuromiQPB2025-08-27
03701416203388EUROMIEuromiQPB2025-08-27
03701416203401EUROMIEuromiQPB2025-08-27
00847399017413MicroAire® Microaire Surgical Instruments LLCQPB2025-08-01
00847399017420MicroAire® Microaire Surgical Instruments LLCQPB2025-08-01
00847399017437MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
00847399017444MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
00847399017451MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
00847399017468MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
00847399017475MicroAire® Microaire Surgical Instruments LLCQPB2025-08-01
00847399017482MicroAire® Microaire Surgical Instruments LLCQPB2025-08-01
00847399017499MicroAire® Microaire Surgical Instruments LLCQPB2025-08-01
00847399017505MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
00847399017512MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
00847399018960MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
14260170880045WAL applicatorHuman Med AGQPB2025-07-30
04260170880352Hydrophobic Filter-setHuman Med AGQPB2025-07-30
14260170880502WAL applicatorHuman Med AGQPB2025-07-30
04260170880802WAL Infiltration CannulaHuman Med AGQPB2025-07-30
04260170880819WAL CannulaHuman Med AGQPB2025-07-30
04260170880840WAL Infiltration CannulaHuman Med AGQPB2025-07-30
04260170880857WAL CannulaHuman Med AGQPB2025-07-30
04260170880871WAL CannulaHuman Med AGQPB2025-07-30
04260170880895WAL CannulaHuman Med AGQPB2025-07-30
04260170880918WAL CannulaHuman Med AGQPB2025-07-30
04260170880932WAL CannulaHuman Med AGQPB2025-07-30
04260170880956WAL CannulaHuman Med AGQPB2025-07-30
04260170880994Biofill CannulaHuman Med AGQPB2025-07-30
04260170881014Biofill Infiltration CannulaHuman Med AGQPB2025-07-30
04260170881038Biofill CannulaHuman Med AGQPB2025-07-30