Recall Z-0169-2015— Cynosure, Inc.

Name: FDA recall Z-0169-2015
Creator: U.S. Food and Drug Administration
Published: 2014-10-09

Class II · Terminated

Class II FDA medical device recall by Cynosure, Inc., initiated 2014-10-09, terminated 2015-03-26. It names one FDA 510(k) clearance: K091169. Product: Elite XPL (Pulsed Light) Handpiece for the Cynosure Elite MPX Laser System. 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.

Recalling firm: Cynosure, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-10-09
Terminated: 2015-03-26
Firm location: Westford, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K091169 — ELITE MPX LASER SYSTEM WITH CRYO CCynosure, Inc.·cleared 2009-05-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Elite XPL (Pulsed Light) Handpiece for the Cynosure Elite MPX Laser System

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.