Device recall
Z-1455-2017: XTRAC Excimer Laser, Model No. AL8000, AL10000 The intended use is targeted UVB…
FDA device recall · Class II · Strata Skin Sciences, Inc.
Key facts
| Recall number (Z-number) | Z-1455-2017 |
|---|---|
| Recall event | 76697 |
| Product | XTRAC Excimer Laser, Model No. AL8000, AL10000 The intended use is targeted UVB phototherapy for treatment of the skin conditions including psoriasis, vitiligo, atopic dermatitis, and leukoderma. |
| Product code | GEX |
| Recalling firm | Strata Skin Sciences, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 5, 2017 |
| FEI number | 3002942014 |
At a glance
- None 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