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Alcon TOTAL30™ for ASTIGMATISM - HSA Registration DE0508325

Access comprehensive regulatory information for Alcon TOTAL30™ for ASTIGMATISM in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508325 and owned by Alcon Laboratories, Inc.. The device was registered on July 25, 2023.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS B
DE0508325
Alcon TOTAL30™ for ASTIGMATISM
HSA Registration Number: DE0508325
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Product Description

TOTAL30™ for Astigmatism (lehfilcon A) toric soft contact lenses are indicated for the optical correction of refractive ametropia (myopia or hyperopia, with astigmatism) in persons with non- diseased eyes. The lenses are intended for daily wear (less than 24 hours while awake), with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, or disposal, as recommended by the eye care professional. Lenses should be discarded and replaced with a new pair each month, or more often, if recommended by the eye care professional.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Ophthalmology
Registration Information
Registration Number
DE0508325
Registration Date
July 25, 2023
Retention Due Date
July 24, 2025
Product Owner
Short Name
Alcon
Address
6201 South Freeway, Fort Worth, Texas 76134-2099, UNITED STATES
Registrant
Address
1 FUSIONOPOLIS WALK, SOLARIS, #08-02, SINGAPORE 138628
Importer
Address
1 FUSIONOPOLIS WALK, SOLARIS, #08-02, SINGAPORE 138628 47 JALAN BUROH, #09-01, SINGAPORE 619491
Model Information
Model Name(s)
Total 30 for Astigmatism (-10.00 D to 0.00 D, +0.25 to +8.00 D), Base Curve: 8.6mm; Diameter: 14.5mm; Cylinder: -0.75 D, -1.25 D, -1.75 D, -2.25 D, -2.75 D; Axis: 10° - 180° (10° steps); Pack of 1, 3, 6
Model Identifier(s)
Total 30 for Astigmatism