Irvine, CA, US · 3 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| OHS | Light Based Over The Counter Wrinkle Reduction | Class II | General, Plastic Surgery | 2 | 2025-10-16 |
| IRP | — | — | — | 1 | 2025-10-30 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2022-08-01 | Class II | Ongoing | Z-1661-2022 | The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emi… | — | Excessive ultraviolet-C radiation |