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
00190776408718MillenniumAvalign Technologies, Inc.GEI2026-08-03
00190776422677MillenniumAvalign Technologies, Inc.GEI2026-08-03
00190776422820MillenniumAvalign Technologies, Inc.GEI2026-08-03
B382SD5657815600Surgical DirectSurgical Direct, Inc.GEI2026-08-03
00190776407445MillenniumAvalign Technologies, Inc.GEI2026-07-31
00190776422332MillenniumAvalign Technologies, Inc.GEI2026-07-31
00190776422516MillenniumAvalign Technologies, Inc.GEI2026-07-31
00198506092640ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-29
00198506093562ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-29
07613327688849MalisSTRYKER CORPORATIONGEI2026-07-29
07613327688856MalisSTRYKER CORPORATIONGEI2026-07-29
07613327688979MalisSTRYKER CORPORATIONGEI2026-07-29
07613327688986MalisSTRYKER CORPORATIONGEI2026-07-29
08800020110688INTRAGen HandpieceJeisys Medical Inc.GEI2026-07-29
B354OSRP80Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP81Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP82Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP83Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP84Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP85Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP89Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
00190776407285MillenniumAvalign Technologies, Inc.GEI2026-07-28
00190776407292MillenniumAvalign Technologies, Inc.GEI2026-07-28
00198506092770ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092886ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092893ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092909ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092916ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092954ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092961ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28