Device recall
Z-1463-2014: FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for…
FDA device recall · Class II · Solta Medical, Inc.
Key facts
| Recall number (Z-number) | Z-1463-2014 |
|---|---|
| Recall event | 67835 |
| Product | FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures. |
| Product code | ONG |
| Recalling firm | Solta Medical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 27, 2015 |
| 510(k) numbers | K101490 |
| FEI number | 3003079710 |
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