Identity
- Trade Name
- Vivaer ARC Stylus FDA UDI
- Generic Name
- Electrosurgical system FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- FG257 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- CAT410 FDA UDI
- Primary DI / UDI-DI
- 08886479300146 FDA UDI
- 510(k) Number
- FDA Product Code
- GEI FDA 510(k)FDA UDI
- GMDN Term
- Electrosurgical system FDA UDI
Classification
- Device Class
- Class II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 878.4400 FDA 510(k)
- Regulation Number
- 878.4400 FDA 510(k)FDA UDI
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
The Vivaer ARC Stylus is a non-invasive medical device designed for the treatment of nasal airway obstruction and chronic rhinitis. It is classified under the product code GEI (General, Plastic Surgery) and is intended for office-based use to address structural nasal obstruction when medical therapies are insufficient.
The device is supplied as a reusable stylus system and has received FDA 510(k) clearance under the Traditional pathway, classified as Substantially Equivalent. It is intended for use in clinical settings by healthcare providers, with no specific sterility requirements stated beyond standard medical device handling. The device is regulated under the advisory committee for General, Plastic Surgery (SU)
Frequently asked questions
What is the Vivaer ARC Stylus primarily used for in clinical practice?
The Vivaer ARC Stylus is designed for office-based treatment of nasal airway obstruction and chronic rhinitis when conventional medical therapies have proven insufficient. It is intended to address structural nasal blockages, making it suitable for patients who require non-invasive intervention beyond medication alone.
Is the Vivaer ARC Stylus a single-use or reusable device, and what does that mean for my practice?
The Vivaer ARC Stylus is supplied as a reusable stylus system, meaning it is intended for repeated use across multiple patients. This design reduces waste and cost per procedure, but your practice must follow standard medical device handling protocols to ensure proper cleaning, sterilization, and maintenance between uses, as no specific sterility requirements are stated beyond general best practices.
How was the Vivaer ARC Stylus approved by the FDA, and what does that mean for its regulatory status?
The device received FDA 510(k) clearance under the Traditional pathway, classified as *Substantially Equivalent* (SESE) to a predicate device. This means the FDA determined it has the same intended use and technological characteristics as an existing approved device, ensuring it meets safety and effectiveness standards for office-based use in treating nasal airway obstruction and chronic rhinitis.
What product code and advisory committee classification does the Vivaer ARC Stylus fall under, and why does that matter?
The device is classified under product code GEI (General, Plastic Surgery) and was reviewed by the General, Plastic Surgery (SU) advisory committee. This classification indicates it is intended for procedures in plastic surgery-related contexts, though its specific use is for nasal airway obstruction—not cosmetic surgery—so clinicians should confirm its alignment with their practice’s procedural scope before adoption.
Who is the manufacturer, and how can I contact them for technical or support inquiries?
The manufacturer is Aerin Medical Inc., headquartered at 232 E Caribbean Dr., Sunnyvale, CA 94089. For technical or support inquiries, you can reach their contact person, Shannon Scott, directly via the provided address or through Aerin Medical’s official channels, though the exact contact method isn’t specified in the data.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Aerin Medical | Rhinitis & Nasal Airway Obstruction Treatment, Nasal Airway Obstruction Treatment | Non-Invasive VivAer, Study of the AERin Medical Vivaer® ARC Stylus for Nasal AirWAY ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K172529 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Aerin Medical Inc.
- FDA Applicant
- Aerin Medical, Inc.
Sources (2)
- FDA 510(k) K172529 24 fields · synced Sep 19, 2026
- FDA UDI 071637e7-97f9-4df3-9e44-3069c24a90c2 37 fields · synced May 27, 2026