Class II — Candela Corporation
| Recalling firm | Candela Corporation |
|---|---|
| Registered facility | Candela Corporation (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Unintended single pulse maybe emitted to handpiece prior to pressing of trigger or footswitch and cause injury. |
| 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 |
| Quantity | 1258 units |
| Distribution | Worldwide distribution: US (nationwide) and Internationally to: Azerbaijan, Bulgaria, Chile, Czech Republic, Greece, Israel, Kuwait, Qatar, Saudi Arabia, Serbia, Turkey, and the United Arab Emirates and to Subsidiaries in Australia, France, Germany, Italy, Japan, Portugal, Spain, and the United Kingdom. |
| Initiated | 2013-11-06 |
| Classified | 2013-11-18 |
| Terminated | 2015-06-08 |
| Recall number | Z-0348-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Candela Corporation (Z-0348-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/66773/
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