FDA Device recall Z-0348-2014
Candela Laser GentleLase Pro, Powered Laser Surgical Instrument for dermatological use - Model number: 9914-00-9015. and Candela Laser Gent…
- FDA Device
- Class II
- terminated
- Published 2013-11-27
On 2013-11-27 the FDA classified a Class II recall of Candela Laser GentleLase Pro, Powered Laser Surgical Instrument for dermatological use - Model number: 9914-00-9015. and Candela Laser Gent… by Candela, citing unintended single pulse maybe emitted to handpiece prior to pressing of trigger or footswitch and cause injury.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0348-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-11-06 |
| Published | 2013-11-27 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Candela |
| Distribution | US |
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
Reason
Unintended single pulse maybe emitted to handpiece prior to pressing of trigger or footswitch and cause injury.
Identifiers
| code_info | GL Pro Model 9914-00-9015:: SN 9914-9015-0005 through 9914-9015-1259 GL Pro LE Model 9914-00-9040: SN 9914-9040-0716 through 9914-9040-1214 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0348-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.