FDA-Device2015-05-06Class II
Light Sheer Desire Diode Laser System with XC Handpiece Accessory options.
Lumenis Limited
Hazard
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.
Sold states
Worldwide distribution. US nationwide (to OR, NM, NY, IL, and CO), Switzerland, Canada, Italy, Great Britain, United Arab Emirates, France, Belgium, India, Israel, Japan, Portugal, Czech Republic, Kuwait, Germany, Spain, Georgia, Armenia, Slovenia, New Zealand, Saudi Arabia, and Russian Federation.
Affected count
117 units
Manufactured in
13 Hayetzira St.,Yokneam Ind. Park, Yokneam, Israel
Products
Light Sheer Desire Diode Laser System with XC Handpiece Accessory options.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1519-2015Don't want to check this manually?
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