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The Viveve System and Viveve 2.0 System are indicated for use in general surgical procedures for electrocoagulation and hemostasis.

The Viveve 2.0 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 and Viveve® 2.0 System consist of four (4) primary components: - An RF Generator to provide the heating energy. The Generator incorporates the Cooling Module to supply coolant which provides the cooling energy. - A hand piece that couples the cooling and heating energy to the tissue through the treatment tip. - A footswitch that allows the user to turn the RF Energy on or off. - 5cm or 8cm Sterile Disposable Treatment Tips. Accessories include: - Coupling Fluid - Cryogen - Return Cable - Return Pad - Power Cord The return pad is the subject of this submission. Previously, Viveve specified and supplied the user with the 3M model 9160 electrosurgical return pad. Viveve is seeking to add additional return pad options for the user with the following characteristics: - United States FDA clearance - A split pad with no cord attached. - Conducted area is between 40 cm2 and 120 cm2. - Measured impedance between 20-140 ohms.

The Viveve System is indicated for use in general surgical procedures for electrocoagulation and hemostasis.

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 resulting in 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 coolant which provides the cooling energy. - . A hand piece that couples the cooling and heating energy to the tissue through the treatment tip. - A footswitch that allows the user to turn the RF Energy on or off. - 5cm or 8cm Sterile Disposable Treatment Tips. The Viveve treatment tips contained in this package are a sterile single use component of the Viveve® System and designed to deliver radiofrequency (RF) energy from the Viveve console. The Viveve treatment tips can only be used in conjunction with the dedicated Viveve® System. Accessories include: - Coupling Fluid ● - Cryogen ● - Return Cable - Return Pad ● - . Power Cord

The Viveve 2.0 System is indicated for use in general surgical procedures for electrocoagulation and hemostasis.

The Viveve® 2.0 System consists of four (4) primary components: - . An RF Generator to provide the heating energy. The Generator incorporates the Cooling Module to supply coolant which provides the cooling energy. - . A hand piece that couples the cooling and heating energy to the tissue through the treatment tip. - A footswitch that allows the user to turn the RF Energy on or off. - . 5cm or 8cm Sterile Disposable Treatment Tips. Accessories include: - Coupling Fluid - Cryogen ● - Return Cable ● - Return Pad ● - . Power Cord