AERIN MEDICAL INC.

Address:2565 Leghorn St.,Mountain View,CA,94043,US

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- Catalog Number : CAT409

Device Description : The InSeca ARC Stylus is a disposable handheld device capable of delivering bipo The InSeca ARC Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue. The InSeca ARC Stylus consists of a handle, shaft and treatment tip. An array of bipolar electrodes is positioned on a non-conductive tip which is attached to a handle via a non-conductive shaft. A temperature sensor is located on the tip to monitor tissue temperature. The Stylus is attached to a temperature-controlled radiofrequency generator (Aerin Console) via a flexible cable.

Device Class : 2

Duns Number: 051512253

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

- Catalog Number : CAT305

Device Description : The Aerin Console is an AC (alternating current) radiofrequency generator. It in The Aerin Console is an AC (alternating current) radiofrequency generator. It incorporates user interface software to control, monitor and regulate RF power delivery to soft tissues via a cable-connected electrosurgical hand piece and electrode. The Aerin Console Set consists of the following items: 1) Aerin Console unit, 2) Power Cord, 3) Foot Switch and is intended for use with one or more Aerin Styli.

Device Class : 2

Duns Number: 051512253

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

- Catalog Number : CAT305-02

Device Description : The Aerin Console Set consists of the following items: 1) Aerin Console unit, 2) The Aerin Console Set consists of the following items: 1) Aerin Console unit, 2) Power Cord, 3) Foot Switch.The Aerin Console is an AC (alternating current) radiofrequency generator. It incorporates user interface software to control, monitor and regulate RF power delivery to soft tissues via a cable-connected electrosurgical hand piece and electrode.

Device Class : 2

Duns Number: 051512253

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

- Catalog Number : CAT309-02

Device Description : The power cord is an accessory for the Aerin Console which is an AC (alternating The power cord is an accessory for the Aerin Console which is an AC (alternating current) radiofrequency generator that incorporates user interface software to control, monitor and regulate RF power delivery to soft tissues via a cable-connected electrosurgical hand piece and electrode.

Device Class : 2

Duns Number: 051512253

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

- Catalog Number : CAT307

Device Description : The foot switch is an accessory for use with the Aerin Console which is an AC (a The foot switch is an accessory for use with the Aerin Console which is an AC (alternating current) radiofrequency generator that incorporates user interface software to control, monitor and regulate RF power delivery to soft tissues via a cable-connected electrosurgical hand piece and electrode.

Device Class : 2

Duns Number: 051512253

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

- Catalog Number : CAT410

Device Description : The Vivaer ARC Stylus is a disposable handheld device capable of delivering bipo The Vivaer ARC Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue. The Vivaer ARC Stylus consists of a handle, shaft and treatment tip. An array of bipolar electrodes is positioned on a non-conductive tip which is attached to a handle via a non-conductive shaft. A temperature sensor is located on the tip to monitor tissue temperature. The Stylus is intended to attach to a temperature-controlled radiofrequency generator (Aerin Console) via a flexible cable.

Device Class : 2

Duns Number: 051512253

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

- Catalog Number : CAT723

Device Description : The VivAer® Stylus is a disposable handheld device capable of delivering bipolar The VivAer® Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue. The VivAer® Stylus consists of a handle, shaft and treatment tip. An array of bipolar electrodes is positioned on a nonconductive tip which is attached to a handle via a nonconductive shaft. A temperature sensor is located on the tip to monitor tissue temperature. The Stylus is attached to a Temperature controlled radiofrequency generator (Aerin Console) via a flexible cable.

Device Class : 2

Duns Number: 051512253

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

- Catalog Number : CAT821

Device Description : The RhinAer Stylus is a disposable handheld device capable of delivering bipolar The RhinAer Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue.The RhinAer Stylus consists of a handle, shaft and treatment tip. An array of bipolar electrodes is positioned on a non-conductive tip which is attached to a handle via a non-conductive shaft. A temperature sensor is located on the tip to monitor tissue temperature. The Stylus is attached to a temperature-controlled radiofrequency generator via a flexible cable. The RhinAer Stylus treats symptoms of chronic rhinitis by modifying the tissues of the nasal airway through the use of low doses of radiofrequency energy to destroy tissue in the posterior nasal nerve regions. The low-power radiofrequency energy generates heat within the submucosal tissue, destroying local tissue, mucous cells, and glands, and creating a coagulation lesion. This destruction of tissue in posterior nasal nerve regions improves symptoms of chronic rhinitis.The RhinAer Stylus tip is temporarily inserted into the nose to access the treatment area. The procedure requires local anesthesia only.

Device Class : 2

Duns Number: 051512253

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Device Description : The power cord is an accessory for the Aerin Console which is an AC (alternating The power cord is an accessory for the Aerin Console which is an AC (alternating current) radiofrequency generator that incorporates user interface software to control, monitor and regulate RF power delivery to soft tissues via a cable-connected electrosurgical hand piece and electrode.

Device Class : 2

Duns Number: 051512253

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

- Catalog Number : CAT1394

Device Description : The RhinAer® Stylus is a disposable handheld device capable of delivering bipola The RhinAer® Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue.The RhinAer® Stylus consists of a handle, shaft and treatment tip. An array of bipolar electrodes is positioned on a non-conductive tip which is attached to a handle via a non-conductive shaft. A temperature sensor is located on the tip to monitor tissue temperature. The Stylus is attached to a temperature-controlled radiofrequency generator via a flexible cable.

Device Class : 2

Duns Number: 051512253

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1