Device recall
Z-2915-2016: VariaBreeze; Catalog number: 7300-0035-2. Podiatry: ablation, vaporization…
FDA device recall · Class II · New Star Lasers, Inc.
Key facts
| Recall number (Z-number) | Z-2915-2016 |
|---|---|
| Recall event | 75048 |
| Product | VariaBreeze; Catalog number: 7300-0035-2. Podiatry: ablation, vaporization, incision, excision, and coagulation of soft tissue including matrixectomy, periungal and subungal warts, plantar warts, radical nail excision, and neuromas. The temporary increase of clear nail in patients with onychomycosis… |
| Product code | GEX |
| Recalling firm | New Star Lasers, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 13, 2016 |
| 510(k) numbers | K103338 |
| FEI number | 1000307100 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database