Recall Z-1519-2015— Lumenis Limited

Name: FDA recall Z-1519-2015
Creator: U.S. Food and Drug Administration
Published: 2015-03-25

Class II · Terminated

Class II FDA medical device recall by Lumenis Limited, initiated 2015-03-25, terminated 2016-06-15. It names one FDA 510(k) clearance: K003614. Product: Light Sheer Desire Diode Laser System with XC Handpiece Accessory options.. Reason: Device software treatment preset parameters for the XC treatment handpiece do not match the Operator Manual, and exceed recommended settings. Operator Manual parameters are lower than indicated for specific hair color and Fitzpatrick skin type resulting in insufficient treatment effect. May result in patient burns and hypopigmentation..

Recalling firm: Lumenis Limited
Classification: Class II
Status: Terminated
Initiated: 2015-03-25
Terminated: 2016-06-15
Firm location: Yokneam, Israel

510(k) clearances named in this recall

1 on FDA's record

K003614 — LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEMCoherent Star·cleared 2001-03-13

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

Light Sheer Desire Diode Laser System with XC Handpiece Accessory options.

Reason for recall

Device software treatment preset parameters for the XC treatment handpiece do not match the Operator Manual, and exceed recommended settings. Operator Manual parameters are lower than indicated for specific hair color and Fitzpatrick skin type resulting in insufficient treatment effect. May result in patient burns and hypopigmentation.

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