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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 NumberS009
Date Received01/30/2026
Decision Date02/25/2026
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 
Approval for an additional servicing supplier for components of the device.
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