Device recall
Z-3047-2017: VASER Amplifier, VASER 2.2 VASERlipo System, Rx Only, 115/230V - 60/50Hz 300VA…
FDA device recall · Class II · Solta Medical Inc
Key facts
| Recall number (Z-number) | Z-3047-2017 |
|---|---|
| Recall event | 77655 |
| Product | VASER Amplifier, VASER 2.2 VASERlipo System, Rx Only, 115/230V - 60/50Hz 300VA The Vaser amplifier is intended for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring (modification of the anatomy). |
| Recalling firm | Solta Medical Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 30, 2020 |
| 510(k) numbers | K110306 |
| FEI number | 3004106598 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
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