Device recall
Z-1010-2011: Fraxel re:store Dual Laser System----a laser surgical instrument for use in…
FDA device recall · Class II · Solta Medical, Inc.
Key facts
| Recall number (Z-number) | Z-1010-2011 |
|---|---|
| Recall event | 57595 |
| Product | Fraxel re:store Dual Laser System----a laser surgical instrument for use in general and plastic surgery and in dermatology. Model Numbers: MC-SYS-SR1500-D-US; MC-SYS-SR1500-D-US-LOANER; MC-SYS-SR1500-D-UPG-US; MC-SYS-SR 1500-0-1 NTL; MC-SYS-SR1500-D-I-LOANER; MC-SYS-SR1500-D-UPG-INTL; Product is… |
| Product code | ONG |
| Recalling firm | Solta Medical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 14, 2011 |
| 510(k) numbers | K091420 |
| 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