RhinAer+ Stylus— 510(k) K260522
Substantially EquivalentAerin Medical, Inc.
FDA 510(k) clearance K260522 for RhinAer+ Stylus, Substantially Equivalent on 2026-05-18. Applicant: Aerin Medical, Inc.. Device class: 2.
Summary
Aerin Medical's RhinAer+ Stylus is filed under GEI, electrosurgical cutting and coagulation devices and accessories.
Class II, 21 CFR 878.4400. The Ear, Nose, Throat review panel handled it as a Traditional 510(k), though the record lists General and Plastic Surgery as the classification panel.
Aerin filed from Mountain View, California. Review took 90 calendar days (February 17 to May 18, 2026).
Clearance details
- Applicant
- Aerin Medical, Inc.
- Product code
- Product code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mountain View,, CA, US
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More clearances from Aerin Medical, Inc.
view allAdverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.