Singapore HSA registration DE0508325
Alcon TOTAL30™ for ASTIGMATISM
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 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.
Product Owner
- Short Name
- Alcon
- Address
- 6201 South Freeway, Fort Worth, Texas 76134-2099, UNITED STATES
Registrant
- Name
- ALCON PTE LTD
- 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
About this record
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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