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HSA · registration DE0510716

ALCON NGENUITY™ 3D VISUALIZATION SYSTEM

SingaporeOphthalmologyClass BAlcon Laboratories, Inc.
Verified
Official record identity
Registration number
DE0510716
Model name
NGENUITY™ 3D VISUALIZATION SYSTEM; NGENUITY™ 3D VISUALIZATION SYSTEM + K400 Plus Keyboard
Model identifier
8065000399; 8065000588
Registration date
May 13, 2025
Source update date
July 29, 2025
Classification
Risk class
Class B
Official value: CLASS B
Published category
Ophthalmology
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Published parties
Product owner
Alcon Laboratories, Inc.
Registrant / registration holder
ALCON PTE LTD
Official description

The NGenuity™ 3D Visualization System is intended to aid in visualization during ophthalmic surgery. It is used for providing magnified stereoscopic images of ocular tissue in real-time or from recordings during ophthalmic surgery.

Additional source fields
Product owner address
6201 South Freeway, Fort Worth, Texas 76134-2099, United States
Registrant address
1 FUSIONOPOLIS WALK, #08-02, SOLARIS, Singapore 138628
About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.