FDA.reportPublic FDA data

UltraShape Power System

Primary DI
07290109950990
Brand
UltraShape Power System
Company
SYNERON MEDICAL LTD
Model
FG71481US
Catalog number
FG71481US
Device description
UltraShape Power System, Packaged
Published
2016-09-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160896000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160896000ULTRASHAPE POWER SYSTEMSyneron Medical, Ltd.2016-07-08OHV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290109950990PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290109950990072901099509907290109950990

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
532685716
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290109952697SA Med. Repl. Cover 25x30mm, 4Hr, Velashape IIIAS83333AS833332017-06-01
07290109952703SA Flat Lrg. Repl. Cover 25x50mm, 4Hr, Velashape III AS87512AS875122017-06-01
17290109950416SA Repl. Small Cvr. 10x13mm (4 Hr) 5-Pk, Velashape IIIKT75061KT750612016-09-26
17290109950423SA Repl. Flat Lrg. Cvr. 25x50mm (4 Hr) 5-Pk, Velashape IIIKT75671KT756712016-09-26
17290109950430SA Repl. Med. Cvr. 25x30mm (4 Hr) 5-Pk, Velashape IIIKT75071KT750712016-09-26
17290109952151LA Repl. Stacking Covers 8 Hr 5PkKT74831KT748312016-09-26
17290109952212LA Replaceable Cover (4 Hr) 5-PkKT75102KT751022016-09-26
37290109950342LA Repl. Cvr. (1Hr) 10-PkKT71745KT717452016-09-26
37290109950359SA Repl. Cvr. (1Hr) 10-Pk, VelaShape II KT71751KT717512016-09-26
37290109950410SA Repl. Small Cvr. 10x13mm (4 Hr) 10-Pk, Velashape IIIKT7425AKT7425A2016-09-26
37290109950427SA Repl. Flat Lrg. Cvr. 25x50mm (4 Hr) 10-Pk, Velashape IIIKT75661KT756612016-09-26
37290109950434SA Repl. Med. Cvr. 25x30mm (4 Hr) 10-Pk, Velashape IIIKT7426AKT7426A2016-09-26
37290109952162LA Repl. Stacking Covers (16 Hr) 10-PkKT74841KT748412016-09-26
07290109950242VelaShape systemFG00131FG001312016-09-20
07290109950259Vsmooth ApplicatorFG00101FG001012016-09-20
07290109950266Vcontour Applicator FG00111FG001112016-09-20
07290109950303Vela Shape II systemFG70321FG703212016-09-20
07290109950310Vela Shape II systemFG70331FG703312016-09-20
07290109950327Vsmooth ApplicatorFG70341FG703412016-09-20
07290109950334Vcontour ApplicatorFG70351FG703512016-09-20

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
00816995027027VASERSOLTA MEDICALOHV2017-12-14
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