FDA.reportPublic FDA data

VIVEVE Hand Piece

Primary DI
00850794007088
Brand
VIVEVE Hand Piece
Company
VIVEVE, INC.
Model
VIVHP01
Catalog number
VIVHP01
Device description
Hand Piece
Published
2016-09-23
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
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082962000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082962000TIVAMED COOLED RF SYSTEM, MODEL 78001Tivamed, Inc.2008-12-04GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850794007088PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850794007088008507940070888507940070880850794007088

GMDN Terms#

Term, Definition table
TermDefinition
Radio-frequency skin contouring systemAn assembly of devices that uses radio-frequency (RF) electromagnetic (EM) energy [typically in the bands below 10 megahertz (MHz)] to generate heat deep within subcutaneous tissues to temporarily minimize the manifestation of cellulite and loose or wrinkled skin through a process of skin regrowth and tightening and local fat cell alteration/destruction. It typically consists of monopolar and/or bipolar applicators attached to an energy-producing generator, typically with a cooling module. The tissues are warmed to produce the desired therapeutic effect; simultaneous cryogen cooling of the epidermis may be employed. This device is not used for the treatment of malignancies.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
025398094
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
008507940070025 cm Treatment TipVIVTT05VIVTT052016-09-23
008507940070195 cm Treatment Tip SVIVTT06VIVTT062016-09-23
008507940070268 cm Treatment TipVIVTT07VIVTT072016-09-23
00850794007057CRYOGEN CANISTERVIVCC03VIVCC032016-10-03
00850794007071COUPLING FLUIDVIVCF02VIVCF022016-10-03
00850794007101VIVEVE Hand Piece SVIVHP01SVIVHP01S2016-09-23
00850794007118VIVEVE ConsoleVIVGE01VIVGE012016-09-23
00850794007132VIVEVE Console SVIVGE01SVIVGE01S2016-09-23
00850794007163Universal Electrosurgical Pad (3M REF 9160) VIVRP02VIVRP022016-10-03
00850794007170VIVEVE FootswitchVIVFS01VIVFS012016-09-23
00850794007187VIVEVE Power CordVIVPC0XVIVPC0X2016-10-03
00850794007194VIVEVE Return CableVIVRC01VIVRC012016-10-03
108507940070095 cm Treatment TipVIVTT05VIVTT052016-09-23
108507940070165 cm Treatment Tip SVIVTT06VIVTT062016-09-23
108507940070238 cm Treatment TipVIVTT07VIVTT072016-09-23
10850794007054CRYOGEN CANISTERVIVCC03VIVCC032016-10-03
10850794007078COUPLING FLUIDVIVCF02VIVCF022016-10-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08886479300306RhinAer+ StylusAerin Medical Inc.GEI2025-09-19
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07613327548204Neptune SafeAirSTRYKER CORPORATIONGEI2025-01-06
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