FDA.reportPublic FDA data

MIRARI Cold Plasma System Insulating Fleece Pouch

Primary DI
00860013508623
Brand
MIRARI Cold Plasma System Insulating Fleece Pouch
Company
General Vibronics, LLC
Model
GV-FL-01
Published
2025-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories
PBXMassager, Vacuum, Radio Frequency Induced Heat

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2
PBXMassager, Vacuum, Radio Frequency Induced HeatGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242553000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242553000MIRARI® Cold Plasma System ( GV-M2-01)General Vibronics, Inc.2024-11-21PBX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860013508623PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860013508623008600135086238600135086230860013508623

GMDN Terms#

Term, Definition table
TermDefinition
Medium-wave diathermy treatment system generatorA component of a medium-wave diathermy treatment system that generates electromagnetic (EM) energy, in the radio-frequency (RF) bands of 0.5 megahertz (MHz) to 1 MHz, applied transcutaneously to provide a deep heat within specific volumes of a patient's body. The energy generated by this device is typically conducted through a hand-operated electrode moved across the treatment area to treat pain, muscle spasms, and joint contractures.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
020484227
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860013508609MIRARI Cold Plasma unit box setGVM2-012025-04-30
00860013508616MIRARI Cold Plasma DriverGVM22025-04-30
00860013508630MIRARI Cold Plasma System ArrayGVPA-10BB2025-04-30
00860013508647Insulating Waterproof ePTFE PouchGV-EPTFE-012025-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776434656MillenniumAvalign Technologies, Inc.GEI2026-10-12
B108890APMMUS00EMFACE controllerBTL INDUSTRIES LIMITEDPBX2026-10-12
B108890APMMUS00EMFACE controllerBTL INDUSTRIES LIMITEDGEI2026-10-12
B108890APSMUS00EXION Face applicatorBTL INDUSTRIES LIMITEDGEI2026-10-12
00190776434083MillenniumAvalign Technologies, Inc.GEI2026-10-09
00190776434199MillenniumAvalign Technologies, Inc.GEI2026-10-09
08809932290082NeoSculpt PlusS&M Medical Inc.PBX2026-10-09
08809932290099NeoSculpt PlusS&M Medical Inc.PBX2026-10-09
08809932290105NeoSculpt PlusS&M Medical Inc.PBX2026-10-09
08809932290112NeoSculpt PlusS&M Medical Inc.PBX2026-10-09
08809932290129NeoSculpt PlusS&M Medical Inc.PBX2026-10-09
08809932290136NeoSculpt PlusS&M Medical Inc.PBX2026-10-09
08809932290143NeoSculpt PlusS&M Medical Inc.PBX2026-10-09
B382SD030861101530Surgical DirectSurgical Direct, Inc.GEI2026-10-09
00190776436186MillenniumAvalign Technologies, Inc.GEI2026-10-08
00190776436544MilleniumAvalign Technologies, Inc.GEI2026-10-08
00190776436599MilleniumAvalign Technologies, Inc.GEI2026-10-08
00840096215380Disposable Bipolar Forceps, 8", 1.5mm Straight TipsKATALYST SURGICAL LLCGEI2026-10-08
00848657078504AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-08
00848657078511AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-08
00848657078528AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-08
00848657083805AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-08
00848657083904AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-08
00840096215335Disposable Bipolar Forceps, 7", 0.5mm Straight TipsKATALYST SURGICAL LLCGEI2026-10-07
00840096215342Disposable Bipolar Forceps, 7", 1.0mm Straight TipsKATALYST SURGICAL LLCGEI2026-10-07
00840096215359Disposable Bipolar Forceps, 7", 1.5mm Straight TipsKATALYST SURGICAL LLCGEI2026-10-07
00840096215366Disposable Bipolar Forceps, 8", 0.5mm Straight TipsKATALYST SURGICAL LLCGEI2026-10-07
00840096215373Disposable Bipolar Forceps, 8", 1.0mm Straight TipsKATALYST SURGICAL LLCGEI2026-10-07
00840096215397Disposable Bipolar Forceps, 9", 0.5mm Straight TipsKATALYST SURGICAL LLCGEI2026-10-07
00840096215403Disposable Bipolar Forceps, 9", 1.0mm Straight TipsKATALYST SURGICAL LLCGEI2026-10-07