Device recall
Z-1353-2020: TLC-2000 Therapeutic Medical Laser System
FDA device recall · Class III · Theralase Inc.
Key facts
| Recall number (Z-number) | Z-1353-2020 |
|---|---|
| Recall event | 84844 |
| Product | TLC-2000 Therapeutic Medical Laser System |
| Product code | NHN |
| Recalling firm | Theralase Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Dec 3, 2020 |
| 510(k) numbers | K151816 |
| FEI number | 3003614490 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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