FDA.reportPublic FDA data

VASER

Primary DI
00816995021520
Brand
VASER
Company
SOLTA MEDICAL
Model
115-0009
Catalog number
115-0009
Device description
KIT, FACE
Published
2019-11-08
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
MUUSystem, Suction, Lipoplasty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUUSystem, Suction, LipoplastyGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816995021520PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816995021520008169950215208169950215200816995021520

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
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
04260632794043TLA Tubing Liposat Pro plusMöller Medical GmbHMUU2026-02-27
00850000712478Autoclavable Suction Jar with Hose Barb extension - 250mLMillennium Medical Technologies, Inc.MUU2026-01-29
00850000712485Autoclavable Suction Jar with Hose Barb extension - 500mLMillennium Medical Technologies, Inc.MUU2026-01-29
00850000712492Autoclavable Suction Jar with Hose Barb extension - 1000mLMillennium Medical Technologies, Inc.MUU2026-01-29
00850000712508Autoclavable Suction Jar with Hose Barb extension - 2000mLMillennium Medical Technologies, Inc.MUU2026-01-29
00850000712515Autoclavable Suction Jar with Hose Barb extension - 3000mLMillennium Medical Technologies, Inc.MUU2026-01-29
00810130455812Medco ManufacturingMedco Manufacturing LLCMUU2026-01-15
00810130455829Medco ManufacturingMedco Manufacturing LLCMUU2026-01-15
00810130455485Medco ManufacturingMedco Manufacturing LLCMUU2025-09-11
00810130455195Medco ManufacturingMedco Manufacturing LLCMUU2025-06-26
00810130455201Medco ManufacturingMedco Manufacturing LLCMUU2025-06-26
08800052308886FPU(Fat Processing Unit)Medikan Co., Ltd.MUU2025-05-20
08800052316904FPU(Fat Processing Unit)Medikan Co., Ltd.MUU2025-05-20
00810130454839Medco ManufacturingMedco Manufacturing LLCMUU2025-02-27
00385640084987SUMMIT MEDICALSummit Medical, Inc.MUU2025-01-22
00385640084994SUMMIT MEDICALSummit Medical, Inc.MUU2025-01-22
00385640085007SUMMIT MEDICALSummit Medical, Inc.MUU2025-01-22
00385640085014SUMMIT MEDICALSummit Medical, Inc.MUU2025-01-22
00385640085021SUMMIT MEDICALSummit Medical, Inc.MUU2025-01-22
03760173235292DISPOSABLE FAT HARVESTING CANNULAAESTHETIC GROUPMUU2024-12-09
07612367011600Single set 2l, clampholderMedela AGMUU2024-05-31
00840329834609BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.MUU2024-04-22
00810130453481Medco ManufacturingMedco Manufacturing LLCMUU2024-04-12
00840329833947BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.MUU2024-04-12
00850034511719Puregraft 50 SystemBimini Technologies LLCMUU2024-01-11
00385640072250SUMMIT MEDICALSummit Medical, Inc.MUU2023-09-26
00850421007269Suction jar stand, for 1 liter, autoclavable canisterMillennium Medical Technologies, Inc.MUU2023-08-07
00850421007283Suction jar stand, for 2 liter autoclavable canisterMillennium Medical Technologies, Inc.MUU2023-08-07
00850421007306Suction jar stand, for 250ml autoclavable canisterMillennium Medical Technologies, Inc.MUU2023-08-07
00850421007313Suction jar, polysulfone, 3 liter, autoclavableMillennium Medical Technologies, Inc.MUU2023-08-07