HSA · registration DE0510520ALCON SMARTCataract DX
- Registration number
- DE0510520
- Model name
- SMARTCataract DX
- Model identifier
- 8065000877
- Registration date
- March 30, 2025
- Source update date
- February 20, 2026
- Risk class
- Class B
- Product owner
- Alcon Laboratories, Inc.
- Registrant / registration holder
- ALCON PTE LTD
The SMARTCataract DX software is indicated for use in the clinical management of ophthalmology patient data. It is used for collecting, transferring, storing, reporting, and displaying ophthalmic and demographic data, and for planning surgical lens replacement procedures and/or tracking outcomes of cataract surgery. The output from the SMARTCataract DX software is not intended to provide primary diagnosis nor to be used on a standalone basis for clinical decision-making.
- Product owner address
- 6201 South Freeway, Fort Worth, Texas 76134-2099, United States
- Registrant address
- 1 FUSIONOPOLIS WALK, #08-02, SOLARIS, Singapore 138628
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.