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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the Original HDE to get an up-to-date view of this device.
 
Trade NameOptune Lua®
Classification Nameelectrical tumor treatment fields
Generic Nameelectrical tumor treatment fields
Applicant
Novocure, GmbH
neuhofstrasse 21
baar 6340
HDE NumberH180002
Supplement NumberS006
Date Received09/11/2025
Decision Date10/08/2025
Product Code
QGZ[ Registered Establishments with QGZ ]
Advisory Committee Anesthesiology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Introduction of additional secondary packaging configurations for the ite transducer arrays to include, in addition to the current package of 20 arrays/box configuration, a 15 arrays/box configuration and a 5 arrays/box configuration.
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