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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
Novocure, GmbH
park 6
ch-6039 root d4
HDE NumberH180002
Supplement NumberS002
Date Received01/22/2021
Decision Date04/02/2021
Product Code
QGZ[ Registered Establishments with QGZ ]
Advisory Committee Anesthesiology
Supplement Typenormal 75 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for modification of the device from the novottf-100l generation 1. 5 model to the novottf-200t generation 2 model.