Device recall
Z-1631-2020: Pharos Excimer Laser, Model: EX-308 - Product Usage: The Pharos EX-308 Excimer…
FDA device recall · Class II · Ra Medical Systems, Inc.
Key facts
| Recall number (Z-number) | Z-1631-2020 |
|---|---|
| Recall event | 85200 |
| Product | Pharos Excimer Laser, Model: EX-308 - Product Usage: The Pharos EX-308 Excimer Laser System is designed to treat the skin disorders psoriasis, vitiligo, atopic dermatitis, and leukoderma using phototherapy. The excimer laser system produces collimated 308 nm radiation, within the invisible region of… |
| Product code | GEX |
| Recalling firm | Ra Medical Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 5, 2021 |
| 510(k) numbers | K062963 |
| FEI number | 3004217728 |
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