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510(k) Data Aggregation
K Number
K180584Device Name
Viveve RF System, Secure
Manufacturer
Viveve Inc.
Date Cleared
2018-04-06
(32 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Viveve Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Viveve System is indicated for use in general surgical procedures for electrocoagulation and hemostasis.
Device Description
The Viveve System utilizes monopolar radiofrequency (RF) energy to selectively heat a given volume of tissue beneath the surface, while cryogen is delivered to the inside of the treatment tip to cool the surface tissue. The generator delivers energy to the treatment tip to create an electric field under the treatment tip (electrode). The mechanism of action is the application of RF energy to the tissue causing coagulation and/or hemostasis. The Viveve System consists of four (4) primary components: An RF Generator to provide the heating energy. The Generator incorporates the Cooling Module to supply the coolant which provides the cooling energy. A hand piece that couples the cooling and heating energy to the tissue through the treatment tip (below). A footswitch that allows the user to turn the RF Energy on or off. 5 cm and 8cm Sterile Disposable Treatment Tips. Accessories include: Coupling Fluid, Cryogen, Return Cable, Return Pad, Power Cord.
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K Number
K162547Device Name
Viveve System
Manufacturer
Viveve Inc.
Date Cleared
2016-10-06
(24 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Viveve Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Viveve System is indicated for use in general surgical procedures for electrocoagulation and hemostasis.
Device Description
The Viveve System utilizes monopolar radiofrequency (RF) energy to selectively heat a given volume of tissue beneath the surface, while cryogen is delivered to the inside of the treatment tip to cool the surface tissue. The generator delivers energy to the treatment tip to create an electric field under the treatment tip (electrode). The mechanism of action is the application of RF energy to the tissue causing coagulation and/or hemostasis.
The Viveve System consists of four (4) primary components:
- An RF Generator to provide the heating energy. The Generator incorporates the Cooling Module to supply the coolant which provides the cooling energy.
- A hand piece that couples the cooling and heating energy to the tissue through the treatment tip (below).
- A footswitch that allows the user to turn the RF Energy on or off.
- Sterile Disposable Treatment Tip.
Accessories include:
- Coupling Fluid
- Cryogen
- Return Cable
- Return Pad
- Power Cord
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