Device recall
Z-0348-2014: Candela Laser GentleLase Pro, Powered Laser Surgical Instrument for…
FDA device recall · Class II · Candela Corporation
Key facts
| Recall number (Z-number) | Z-0348-2014 |
|---|---|
| Recall event | 66773 |
| Product | Candela Laser GentleLase Pro, Powered Laser Surgical Instrument for dermatological use - Model number: 9914-00-9015. and Candela Laser GentleLase Pro LE, Model number: 9914-00-9040 |
| Product code | GEX |
| Recalling firm | Candela Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 8, 2015 |
| 510(k) numbers | K024260, K024335, K972767 |
| FEI number | 1218402 |
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