FDA.reportPublic FDA data

VASER

Primary DI
00816995027027
Brand
VASER
Company
SOLTA MEDICAL
Model
P005999R
Catalog number
P005999R
Device description
Liposonix System Model 2, Refurbished
Published
2017-12-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OHVFocused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHVFocused Ultrasound For Tissue Heat Or Mechanical Cellular DisruptionGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816995027027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816995027027008169950270278169950270270816995027027

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasonic body contouring systemAn assembly of devices intended for the transdermal application of ultrasonic energy to rupture targeted fat cells in areas where they tend to enlarge (e.g., hips, thighs, abdomen, buttocks), to reshape those areas for cosmetic purposes. The assembly typically consists of a mains electricity (AC-powered) ultrasonic energy generator with user controls/interface and an ultrasonic transducer used to transmit the energy to a target area to emulsify fat cells; it may include a video imaging system that takes into account real-time body movement to precisely position the transducer during treatment. The use of this system may serve as a noninvasive outpatient procedure alternative to liposuction.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079999584
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816995027461CLEAR+BRILLIANT TOUCHCBT-CONSOLE-RCBT-CONSOLE-R2020-09-01
00816995027478CLEAR+BRILLIANT TOUCHCBT-HP-1440-RCBT-HP-1440-R2020-09-01
00816995027485CLEAR+BRILLIANT TOUCHCBT-HP-1927-RCBT-HP-1927-R2020-09-01
00816995027317CLEAR+BRILLIANT TOUCHCBT-HP-1440CBT-HP-14402020-07-13
00816995027324CLEAR+BRILLIANT TOUCHCBT-HP-1927CBT-HP-19272020-07-13
00816995027331CLEAR+BRILLIANT TOUCHCBT-KEY-12CBT-KEY-122020-07-13
00850608002476PowerX Lipo System110-0020110-00202016-09-23
00850608002544PowerX Lipo System110-0039110-00392016-09-23
00816995020233Fraxel re:store DUAL Laser SystemMC-SYS-SR1500-D-USMC-SYS-SR1500-D-US2016-09-23
00816995026921PowerX Lipo System110-0020R110-0020R2017-12-14
00816995026990PowerX Lipo System110-0039R110-0039R2017-12-14
00816995027010Fraxel re:store DUAL Laser SystemMC-SYS-SR1500-D-USRMC-SYS-SR1500-D-USR2017-12-14
00816995027300CLEAR+BRILLIANT TOUCHCBT-CONSOLECBT-CONSOLE2020-07-13
00816995027799Fraxel FTXMCSYSFTX-RMCSYSFTX-R2025-04-02
00816995027805Fraxel FTXMCSYSFTXMCSYSFTX2025-04-02
00816995027249THERMAGETF-3-60TF-3-602019-11-08
00816995027256THERMAGETF-3-30TF-3-302019-11-08
00850608002124ThermageTG-2BTG-2B2016-09-23
00850608002131ThermageTC-1-4TC-1-42016-09-23
00850608002148ThermageTC-2-4TC-2-42016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290018152089Sofwave ApplicatorSOFWAVE MEDICAL LTDOHV2025-02-16
00840763101145Ulthera System Control Unit PRIMEUlthera, Inc.OHV2024-04-10
00840763101152Ulthera System HandpieceUlthera, Inc.OHV2024-04-08
07290018152058Sofwave ApplicatorSOFWAVE MEDICAL LTDOHV2023-04-24
07290018152065Sofwave ApplicatorSOFWAVE MEDICAL LTDOHV2023-04-24
07290018152027Sofwave ApplicatorSOFWAVE MEDICAL LTDOHV2021-05-27
08800020100009LIPOcelJeisys Medical Inc.OHV2020-02-25
07290018152003SofwaveSOFWAVE MEDICAL LTDOHV2019-11-10
07290018152010Sofwave ApplicatorSOFWAVE MEDICAL LTDOHV2019-11-10
00840763100025Ulthera System Transducer DS 7-3.0 Ulthera, Inc.OHV2019-07-18
00840763100834Ulthera System TransducerUlthera, Inc.OHV2018-04-27
00840763100841Ulthera System TransducerUlthera, Inc.OHV2018-04-27
00840763100858Ulthera System TransducerUlthera, Inc.OHV2018-04-27
00840763100865Ulthera System TransducerUlthera, Inc.OHV2018-04-27
00840763100889Ulthera System TransducerUlthera, Inc.OHV2018-04-27
00840763100896Ulthera System TransducerUlthera, Inc.OHV2018-04-27
00840763100902Ulthera System Control UnitUlthera, Inc.OHV2018-04-27
00840763100919Ulthera System HandpieceUlthera, Inc.OHV2018-04-27
07290109952741UltraShape Power System, PackagedSYNERON MEDICAL LTDOHV2018-03-26
00840763100018Ulthera System HandpieceUlthera, Inc.OHV2017-05-23
00840763100261Ulthera System HandpieceUlthera, Inc.OHV2017-05-23
00840763100476Ulthera SystemUlthera, Inc.OHV2017-05-23
00840763100483Ulthera System HandpieceUlthera, Inc.OHV2017-05-23
07290109952451UltraShape System, Packaged for USSYNERON MEDICAL LTDOHV2017-01-17
00840763100032Ulthera System TransducerUlthera, Inc.OHV2016-12-14
00840763100049Ulthera System TransducerUlthera, Inc.OHV2016-12-14
00840763100056Ulthera System TransducerUlthera, Inc.OHV2016-12-14
00840763100308Ulthera System HandpieceUlthera, Inc.OHV2016-12-14
00840763100315Ulthera System TransducerUlthera, Inc.OHV2016-12-14
00840763100339Ulthera System TransducerUlthera, Inc.OHV2016-12-14