FDA-Device2016-05-25Class II
Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-1014971).
Lumenis Ltd
Hazard
Lumenis Ltd Announces a Field Action of the M22 IPL Acne Filters for the Lumenis M22 IPL Hand Piece due to the Risk of Superficial Burns When Using the Device.
Sold states
Distributed in the states of GA, CA, CO, CT, KY, LA, MA, MN, NJ, NY, RI, and SC, and the countries of Italy, Germany, France, and China.
Affected count
33 filters
Manufactured in
13 Hayetzira St.,Yokneam Ind. Park, N/A, Yokneam, N/A, Israel
Products
Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-1014971).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1669-2016Don't want to check this manually?
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