Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009453079

FEI Number

3009453079

Entity Name

NOVOCURE LTD

City/State/Country

Haifa Northern, IL

Establishment Address

Topaz Bldg., Matam Center, Haifa Northern 3190500, IL

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Novocure Ltd (Owner Number: 10039906)

Owner / Operator Contact Address

Neuhofstrasse 21, Baar, CH-ZG 6340, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P230042

All Registered Proprietary Names

Transducer Array Optune Treatment Kit Optune Lua Treatment Kit Transducer Array Optune Lua for NSCLC

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NZK	Stimulator, Low Electric Field, Tumor Treatment	Unknown	Class 3	N/A	2012-02-21
QGZ	Electrical Tumor Treatment Fields	Unknown	Class 3	N/A	2019-12-06
SDA	Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer	Unknown	Class 3	N/A	2024-12-15

Official Correspondent

Lori Burns

US Agent Details

Jennifer Henderson Business: Novocure Inc Email: jhenderson@novocure.com Phone: (603) 5014290

Related Public Records

Same Entity

Novocure Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009453079. Last updated year: 2026. Please use registration number 3009453079 when referencing this establishment in official correspondence.