Class II — Cynosure, Inc.
| Recalling firm | CYNOSURE, LLC |
|---|---|
| Registered facility | CYNOSURE, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | If the laser system is turned on and the user adjusts, installs or removes the XPL pulsed light handpiece, there is a potential risk of an electrical shock |
| Product | Elite XPL (Pulsed Light) Handpiece for the Cynosure Elite MPX Laser System |
| Quantity | 322 units |
| Distribution | Worldwide Distribution - Nationwide Distribution and the countries of : Australia, Canada, France, Germany, Italy, Netherlands, Ukraine and UK. |
| Initiated | 2014-10-09 |
| Classified | 2014-11-04 |
| Terminated | 2015-03-26 |
| Recall number | Z-0169-2015 |
| 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 — Cynosure, Inc. (Z-0169-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/69463/
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