FDA.reportPublic FDA data

Sofwave

Primary DI
07290018152003
Brand
Sofwave
Company
SOFWAVE MEDICAL LTD
Model
FG00001
Catalog number
FG00001
Device description
FOCUSED ULTRASOUND FOR TISSUE HEAT OR MECHANICAL CELLULAR DISRUPTION AND A POWERED MUSCLE STIMULATOR (EMS)
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
NGXStimulator, Muscle, Powered, For Muscle Conditioning
NXGFluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion
OHVFocused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NGXStimulator, Muscle, Powered, For Muscle ConditioningPhysical Medicine2
NXGFluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And DeletionUnknown3
OHVFocused Ultrasound For Tissue Heat Or Mechanical Cellular DisruptionGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191421000
K211483000
K223237000
K230019000
K230820000
K231537000
K232455000
K233104000
K240687000
K241685000
K250146000

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
K230019000SofWave SystemSofwave Medical, Ltd.2023-03-14OHV
K230820000SofWave SystemSofwave Medical, Ltd.2023-04-18OHV
K231537000SofWave SystemSofwave Medical, Ltd.2023-08-28OHV
K232455000SofWave SystemSofwave Medical, Ltd.2023-12-14OHV
K233104000SofWave SystemSofwave Medical, Ltd.2023-12-22OHV
K240687000SofWave SystemSofwave Medical, Ltd.2024-05-30OHV
K241685000SofWave SystemSofwave Medical, Ltd.2024-08-07NGX
K250146000SofWave SystemSofwave Medical, Ltd.2025-04-18NGX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290018152003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290018152003072900181520037290018152003

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
Manufacturing date on label
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
07290018152089Sofwave ApplicatorFG00004FG000042025-02-16
07290018152058Sofwave ApplicatorFG00003FG000032023-04-24
07290018152010Sofwave ApplicatorFG00002FG000022019-11-10
07290018152065Sofwave ApplicatorFG00003-RFG00003-R2023-04-24
07290018152027Sofwave ApplicatorFG00002-RFG00002-R2021-05-27

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Primary DI, Brand, Company table
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