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Alcon Air Optix Night and Day Aqua (lotrafilcon A) soft contact lens - HSA Registration DE0008104

Access comprehensive regulatory information for Alcon Air Optix Night and Day Aqua (lotrafilcon A) soft contact lens in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0008104 and owned by Alcon Laboratories, Inc.. The device was registered on December 02, 2011.

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 C
DE0008104
Alcon Air Optix Night and Day Aqua (lotrafilcon A) soft contact lens
HSA Registration Number: DE0008104
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Product Description

It is intended for the optical correction of vision in persons with nondiseased eyes with minimal astigmatism that does not interfere with vision. Lotrafilcon A contact lenses may be worn for daily wear or extended wear for up to 30 nights and days continuous wear as recommended by an eye care professional. The lenses are intended for monthly replacement. The lenses are also intended for therapeutic use as a bandage to protect the cornea, to relieve corneal pain, and to aid corneal healing in the treatment of acute or chronic ocular pathologies such as bullous keratopathy, corneal erosions, entropion, corneal edema, and corneal dystrophies as well as post surgical conditions resulting from cataract extraction and corneal surgery. Contact lenses for therapeutic use can also provide optical correction during healing if required. The lenses are also intended for therapeutic use as a bandage to protect the cornea, to relieve corneal pain, and to aid corneal healing in the treatment of acute or chronic ocular pathologies such as bullous keratopathy, corneal erosions, entropion, corneal edema, and corneal dystrophies as well as post surgical conditions resulting from cataract extraction and corneal surgery. Contact lenses for therapeutic use can also provide optical correction during healing if required.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Ophthalmology
HSA Product Code
HSAMDB00108
HS Code
90013000
Registration Information
Registration Number
DE0008104
Registration Date
December 02, 2011
Change Notification Approval Date
October 03, 2023
Retention Due Date
December 01, 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 133 TUAS SOUTH AVENUE 3, SINGAPORE 637550
Model Information
Model Name(s)
AIR OPTIX Night & Day AQUA (-10.00D to -8.50D, -8.00D to +6.00D) (pack of 1, 3, 6)
Model Identifier(s)
AIR OPTIX Night & Day AQUA