Device recall
Z-1624-2012: Pelleve Non-Ablative Wrinkle Treatment Handpiece, Product Codes D110FSHP…
FDA device recall · Class II · Ellman International, Inc.
Key facts
| Recall number (Z-number) | Z-1624-2012 |
|---|---|
| Recall event | 61801 |
| Product | Pelleve Non-Ablative Wrinkle Treatment Handpiece, Product Codes D110FSHP, D115FSHP (reusable) --- Pelleve --- Elegance through science --- Contents: One (1) Pelleve Handpiece (Reusable) --- Non-ablative treatment of mild to moderate facial wrinkles and rhytids for skin phototypes I-IV. |
| Product code | GEI |
| Recalling firm | Ellman International, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 12, 2016 |
| 510(k) numbers | K082834 |
| FEI number | 2428235 |
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