Mountain View,, CA, US · 5 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | Class II | General, Plastic Surgery | 4 | 2026-05-18 |
| BSP | — | — | — | 1 | 2024-03-21 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2024-11-12 | Class II | Ongoing | Z-0808-2025 | Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 (5-pack), sterile. | — | Some units in a single production lot were programmed incorrectly which will result in the VivAer Stylus being incorrectly recognized as RhinAer Stylus when con… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-05-18 | K260522 | RhinAer+ Stylus | GEI | Class II | General, Plastic Surgery |
| 2024-12-10 | K242630 | Aerin Console | GEI | Class II | General, Plastic Surgery |
| 2024-03-21 | K240253 | Reach Needle | BSP | — | — |
| 2022-07-29 | K221907 | RhinAer® Stylus (FG1393) | GEI | Class II | General, Plastic Surgery |
| 2020-04-13 | K200300 | VivAer Stylus | GEI | Class II | General, Plastic Surgery |