← Product Code [GEI](/productcode/GEI) · K260522

# RhinAer+ Stylus (K260522)

_Aerin Medical, Inc. · GEI · May 18, 2026 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K260522

## Device Facts

- **Applicant:** Aerin Medical, Inc.
- **Product Code:** [GEI](/productcode/GEI.md)
- **Decision Date:** May 18, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4400
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery
- **Attributes:** Therapeutic

## Indications for Use

The RhinAer+ Stylus is indicated for use in otorhinolaryngology (ENT) surgery for the destruction of soft tissue in the nasal airway, including in posterior nasal nerve regions in patients with chronic rhinitis.

## Device Story

RhinAer+ Stylus is a bipolar radiofrequency (RF) probe used in ENT surgery; delivers RF energy to destroy soft tissue in nasal airway/posterior nasal nerve regions. Device consists of integrated handle, shaft, and electrode; connects to Aerin Console. Operates at 4 Watts and 60°C. Used by physicians to treat chronic rhinitis. Modification from predicate (K221907) involves updated labeling to include observational clinical data regarding patients with comorbid migraine. No changes to design, energy delivery, or intended use. Output affects clinical decision-making by providing information on potential migraine-related symptom improvements alongside rhinitis treatment.

## Clinical Evidence

Prospective, multi-center, non-randomized, non-significant risk clinical study evaluated RhinAer+ Stylus in patients with chronic rhinitis and comorbid migraine. Endpoints included Reflective Total Nasal Symptom Score (rTNSS), Monthly Migraine Headache Days (MMHD), and Migraine Disability Assessment (MIDAS). Results showed improvements in rTNSS, reductions in MMHD, and improved MIDAS scores at 3, 6, and 12-month follow-ups. Study did not raise new safety questions.

## Technological Characteristics

Bipolar radiofrequency electrosurgical probe. Design includes integrated cable, shaft, handle, and electrode. Output power: 4 Watts. Treatment temperature: 60°C. Compatibility: Aerin Console. Sterilization: ETO.

## Regulatory Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

## Predicate Devices

- RhinAer Stylus ([K221907](/device/K221907.md))

## Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

May 18, 2026

Aerin Medical, Inc.
Teri Feeley
Regulatory Affairs Manager
2565 Leghorn St.
Mountain View, California 94043

Re: K260522
Trade/Device Name: RhinAer+ Stylus
Regulation Number: 21 CFR 878.4400
Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories
Regulatory Class: Class II
Product Code: GEI
Dated: February 15, 2026
Received: February 17, 2026

Dear Teri Feeley:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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K260522 - Teri Feeley
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-

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K260522 - Teri Feeley
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

JOYCE C. LIN -S

for Shu-Chen Peng, Ph.D.
Assistant Director
DHT1B: Division of Dental and ENT Devices
OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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|  Indications for Use  |   |   |
| --- | --- | --- |
|  Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K260522 | ?  |
|  Please provide the device trade name(s). |   | ?  |
|  RhinAer+ Stylus  |   |   |
|  Please provide your Indications for Use below. |   | ?  |
|  The RhinAer+ Stylus is indicated for use in otorhinolaryngology (ENT) surgery for the destruction of soft tissue in the nasal airway, including in posterior nasal nerve regions in patients with chronic rhinitis.  |   |   |
|  Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ?  |

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Aerin MEDICAL

510(k) Summary

General Information

|  Submitter Information  |   |
| --- | --- |
|  Company: | Aerin Medical Inc.  |
|  Submitter Address: | 2565 Leghorn St. Mountain View, CA 94043  |
|  Contact Person: | Teri Feeley Regulatory Affairs Manger Phone: 210-827-1618  |
|  Establishment Registration Number: | 3011625895  |
|  Date Prepared: | 18 May 2026  |
|  Name of Device  |   |
|  Brand Name: | RhinAer+ Stylus  |
|  Common Name: | Radiofrequency probe  |
|  Classification Name: | Electrosurgical cutting and coagulation device and accessories  |
|  Classification Panel | General and Plastic Surgery  |
|  Device Class: | Class II  |
|  Product Code: | GEI  |
|  CFR Regulation: | 21 CFR 878.4400  |
|  Predicate Device: | RhinAer Stylus (K221907)  |
|  Device Description  |   |
|  The RhinAer+ Stylus is functionally unchanged from the predicate device (K221907) in design and technological characteristics to generate and deliver bipolar RF energy for use in otorhinolaryngology (ENT) surgery for destruction of soft tissue in the nasal airway. The RhinAer+ Stylus labeling has been modified to include observational information from a clinical study conducted in patients with chronic rhinitis with comorbid migraine.  |   |
|  Indications for Use  |   |
|  The RhinAer+ Stylus is indicated for use in otorhinolaryngology (ENT) surgery for the destruction of soft tissue in the nasal airway, including in posterior nasal nerve regions in patients with chronic rhinitis.  |   |

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Aerin MEDICAL

510(k) Summary

|  Summary of Technological characteristics compared to the predicate device  |   |   |
| --- | --- | --- |
|  The subject device has the same technological characteristics as the predicate including the principle of operation, performance, and design features.  |   |   |
|  Characteristic | Subject Device | Predicate Device (K221907)  |
|  Intended Use and Indications for Use | Same | The RhinAer Stylus is indicated for use in otorhinolaryngology (ENT) surgery for the destruction of soft tissue in the nasal airway, including in posterior nasal nerve regions in patients with chronic rhinitis.  |
|  Design Configuration | Same | Integrated cable, shaft, handle and electrode  |
|  Energy Type | Same | Bipolar radiofrequency  |
|  Treatment Temperature Range | Same | 60°C  |
|  Output Power | Same | 4 Watts  |
|  Stylus Compatibility | Same | Aerin Console  |
|  Sterilization | Same | ETO  |

|  Summary of non-clinical test  |   |   |
| --- | --- | --- |
|  Device performance testing was not required for this modification.  |   |   |

|  Summary of clinical test  |   |   |
| --- | --- | --- |
|  The subject device labeling has been revised to include clinical data as observational information to inform clinicians of the results observed in a subset of chronic rhinitis patients who also have comorbid migraine. A prospective, multi-center, non-randomized, non-significant risk clinical study was conducted to evaluate the effects of RhinAer+ Stylus use in patients with chronic rhinitis and comorbid migraine. The following outcome measures were evaluated: • Reflective Total Nasal Symptom Score (rTNSS) • Monthly Migraine Headache Days (MMHD) • Migraine Disability Assessment (MIDAS) The study showed improvements in migraine-related outcomes, including reductions in MMHD and MIDAS scores, as well as improvements in chronic rhinitis symptoms as measured by rTNSS, at 3-, 6-, and 12-month follow-up visits. The clinical study did not raise different questions of safety.  |   |   |

|  Conclusion  |   |   |
| --- | --- | --- |
|  The subject device is substantially equivalent to the predicate device based on a comparison of the device performance and technological characteristics. Labeling language has been modified to include clinical data as observational information without changing the intended use. A risk-based assessment did not identify new risks or significantly modify existing risks. Therefore, the subject device is substantially equivalent to the predicate device.  |   |   |

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**Source:** [https://fda.innolitics.com/device/K260522](https://fda.innolitics.com/device/K260522)

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