FDA.reportPublic FDA data

VASER

Primary DI
00816995026266
Brand
VASER
Company
SOLTA MEDICAL
Model
130-0095
Catalog number
130-0095
Device description
SKIN PORT,CORK, START. KIT,4PK
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
00816995026266PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816995026266008169950262668169950262660816995026266

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasonic surgical system generatorAn electrically-powered component of an ultrasonic surgical system intended to generate a high frequency electrical current that is converted, typically within a handpiece, into an ultrasonic oscillation to fragment hard and/or soft tissue cells upon contact with a vibrating tip. It is used in a variety of surgical disciplines (e.g., arthroscopy, gynaecology, neurosurgery, dental/craniomaxillofacial reconstructive surgery); it is not dedicated to dental applications. It provides the controls and monitoring functions for the system during the procedure, and typically regulates energy to the system via a foot-switch; integrated suction/aspiration function may be included.

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
false
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