aerinmedical.comAerin Console
Aerin Medical, Inc.
AERIN MEDICAL INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3011625895 | 3011625895 | AERIN MEDICAL INC. | 1 | N | 2026-01-01 | 2565 Leghorn St. Mountain View CA US 94043 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 08886479300023 | InSeca ARC Stylus - 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. | 8334848237 | customerservice@aerinmedical.com |
| 08886479300030 | Aerin Console - 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. | 8334848237 | customerservice@aerinmedical.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 189151 | 1857887231 | K260522 | RhinAer+ Stylus | GEI | 2026-05-18 |
| 189151 | 1141051068 | K242630 | Aerin Console | GEI | 2024-12-10 |
| 189151 | 1791850412 | K240253 | Reach Needle | BSP | 2024-03-21 |
| 189151 | 1988387119 | K221907 | RhinAer® Stylus (FG1393) | GEI | 2022-07-29 |
| 189151 | 1611509517 | K200300 | VivAer Stylus | GEI | 2020-04-13 |
| 189151 | 1943468596 | K192471 | RHIN1 Stylus | GEI | 2019-12-20 |
| 189151 | 1255976242 | K172529 | Vivaer ARC Stylus | GEI | 2017-12-05 |
| 189151 | 1664573352 | K162810 | InSeca ARC Stylus, Aerin Console | GEI | 2017-01-11 |
Product Codes Associated With Registrations#
PMN#
Reach Needle
Aerin Medical, Inc.
RhinAer® Stylus (FG1393)
Aerin Medical Inc.
VivAer Stylus
Aerin Medical Inc
RHIN1 Stylus
Aerin Medical Inc.
Vivaer ARC Stylus
Aerin Medical, Inc.
InSeca ARC Stylus, Aerin Console
Aerin Medical, Inc.
Aerin Medical Stylus
Aerin Medical, Inc.
Aerin Medical Wand Model FG011
Aerin Medical, Inc.
GUDID#
RhinAer+ Stylus - 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 are 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.
2025-09-19
RhinAer Stylus - 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.
2020-02-03
VivAer® Stylus - 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.
2020-10-19
Vivaer ARC Stylus - 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.
2017-12-19
InSeca ARC Stylus - 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.
2017-12-19
RhinAer® Stylus - 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.
2022-08-19
Aerin Console - 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.
2017-12-19
VivAer® Stylus - 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.
2024-01-05
Aerin Console Set - 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.
2017-12-19
Aerin Console Set - The Aerin Consoleis an AC(alternatingcurrent)radiofrequencygenerator. Itincorporates userinterfacesoftware tocontrol, monitorand regulate RFpower delivery tosoft tissues via acable-connectedelectrosurgicalhand piece andelectrode. TheAerin Consoleconsists of thefollowing items:1) Aerin Consoleunit, 2) PowerCord, 3) FootSwitch.
2024-12-18
Aerin Console - The Aerin Consoleis an AC(alternatingcurrent)radiofrequencygenerator. Itincorporates userinterfacesoftware tocontrol, monitorand regulate RFpower delivery tosoft tissues via acable-connectedelectrosurgicalhand piece andelectrode. TheAerin Consoleconsists of thefollowing items:1) Aerin Consoleunit, 2) PowerCord, 3) FootSwitch
2024-12-18
Reach Needle - Single use anesthesia needle
2024-06-10
Reach Needle - Single use anesthesia needle
2024-06-10
Power Cord (UK) 15 FT - 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.
2023-10-19
Power Cord (OUS) 15 FT - 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.
2023-10-19
Power Cord (UK) - 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.
2023-10-19
Power Cord (OUS) - 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.
2023-10-19
Sterile Aquasonic 100 Ultrasound Transmission Gel - Sterile Aquasonic 100 Ultrasound Transmission Gel may be used:• On or near broken skin, such as fresh surgical site or open wound where sterility is indicated.• On mucous membranes and in natural body orifices.• For patients where cross contamination is a concern such as:• Patients with immunodeficiency or on immunosuppressive therapy.• Neonates or critically ill pediatric patients.• Critically ill patients or patients in contact, airborne or droplet transmission-based precautions.
2017-12-19
Power Cord 15 ft (US) - 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.
2021-07-15
Foot Switch - 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.
2017-12-19
Power Cord - 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.
2017-12-19