| K-number | K242630 |
| Device name | Aerin Console |
| Applicant | Aerin Medical, Inc. |
| Product code | GEI |
| Device class | Class II |
| Decision date | Dec 10, 2024 |
| Decision | Substantially Equivalent |
| Regulation | — |
The Aerin Console is a radiofrequency (RF) generator that works with Aerin Medical Stylus handpieces (RhinAer and VivAer) to deliver bipolar RF energy to soft tissues. It consists of an RF generator, power cord, and foot switch with integrated software to control and monitor power delivery. The device is intended for use in small clinic, office, or hospital environments.
The subject device has identical technological characteristics to the predicate: same generator/power cord/foot switch design, bipolar radiofrequency energy type, 50-70°C treatment temperature range, 3-5 watts output power, and compatibility with Aerin Medical Stylus handpieces (RhinAer and VivAer).
Electrical Safety and EMC: ISO 60601-1, ISO 60601-1-2, IEC 60601-4-2, 47 CFR Part 15 Subpart B, 47 CFR Part 27. Software validation: IEC 62304. Device Security: IEC 81001-5-1.
The subject device maintains identical design configuration, energy type, treatment temperature range, output power, and stylus compatibility as the predicate device K162810. Since all key technological characteristics are the same and non-clinical testing demonstrates compliance with applicable standards, the minor differences between versions do not raise new questions of safety or effectiveness.
View the full FDA submission: accessdata.fda.gov