Device recall
Z-0005-2014: The product is labeled in part "***Surgical Laser Technologies, Inc…
FDA device recall · Class II · PhotoMedex, Inc.
Key facts
| Recall number (Z-number) | Z-0005-2014 |
|---|---|
| Recall event | 64454 |
| Product | The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyrogenic***. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH… |
| Product code | GEX |
| Recalling firm | PhotoMedex, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 16, 2014 |
| 510(k) numbers | K082721 |
| FEI number | 3000206133 |
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