FDA.reportPublic FDA data

Sofwave Applicator

Primary DI
07290018152010
Brand
Sofwave Applicator
Company
SOFWAVE MEDICAL LTD
Model
FG00002
Catalog number
FG00002
Device description
The SofWave System is an ultrasound system intended for aesthetic purposes. The SofWave System consists of two main functional components: 1) the console and 2) the applicator. The applicator component of SofWave System exists in three forms to allow the user treatment flexibility, This applicator is the regular size (lift) applicator, designed with flat tip to allow the user treatment flexibility and easier access to all treatment areas.
Published
2019-11-10
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191421000
K211483000
K223237000
K231537000
K233104000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191421000Sofacia SystemSofwave Medical, Ltd.2019-09-09OHV
K211483000SofWave SystemSofwave Medical, Ltd.2021-11-15OHV
K223237000SofWave SystemSofwave Medical, Ltd.2022-12-16OHV
K231537000SofWave SystemSofwave Medical, Ltd.2023-08-28OHV
K233104000SofWave SystemSofwave Medical, Ltd.2023-12-22OHV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290018152010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290018152010072900181520107290018152010

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasonic skin contouring systemA mobile assembly of electrically-powered devices intended to temporarily minimize the manifestation of cellulite, loose or wrinkled skin, and/or facial lines through the extracorporeal application of high-intensity/frequency ultrasound [e.g., high intensity focused ultrasound (HIFU)]. It is typically used on the head and neck where it generates low levels of heat in the targeted tissue to stimulate the cells for elastin/collagen production and tissue rejuvenation. It typically consists of a high-intensity/frequency generator/control unit, handpiece, transducer cartridge and connection cable.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Fahrenheit158 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
531962539
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290018152096SofWave Pure Impact Wireless Stimulation ModuleFG00014-RFG00014-R2026-02-12
07290018152164Pure ImpactKT00040KT000402026-02-01
07290018152133SofWave Pure Impact Stimulation Modules Charging StationFG00013FG000132024-01-07
07290018152140SofWave Pure Impact Wireless Stimulation ModuleFG00014FG000142024-01-07
17290018152154SofWave Pure Impact Electode PadsFG00015FG000152024-01-07
07290018152171Pure Impact Touch control ModuleFG00016FG000162025-09-08
07290018152003SofwaveFG00001FG000012019-11-10
07290018152089Sofwave ApplicatorFG00004FG000042025-02-16
07290018152058Sofwave ApplicatorFG00003FG000032023-04-24
07290018152065Sofwave ApplicatorFG00003-RFG00003-R2023-04-24
07290018152027Sofwave ApplicatorFG00002-RFG00002-R2021-05-27

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
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
00840763100339Ulthera System TransducerUlthera, Inc.OHV2016-12-14