Singapore HSA registration DE0018378
Alcon Air Optix Plus Hydraglyde Contact Lenses
Singapore·CLASS B·ALCON LABORATORIES INC·Registered July 19, 2016Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Ophthalmology
Registration information
- Registration Number
- DE0018378
- Registration Date
- July 19, 2016
- Change Notification Approval Date
- August 17, 2022
- Retention Due Date
- July 18, 2025
Product description
AIR OPTIX* plus HydraGlyde* (lotrafilcon B) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity. The lenses are to be used for daily wear or extended wear for up to 6 nights of continuous wear with removal for disposal, or cleaning and disinfection (chemical, not heat) prior to reinsertion, 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 LABORATORIES INC
- Address
- 6201 SOUTH FREEWAY, FORT WORTH TEXAS 76134, UNITED STATES
Registrant
- Name
- ALCON PTE LTD
- Address
- 1 FUSIONOPOLIS WALK, SOLARIS, #08-02, SINGAPORE 138628
Importer
- Name
- ALCON PTE LTD
- Address
- 1 FUSIONOPOLIS WALK, SOLARIS, #08-02, SINGAPORE 138628
Model information
- Model Name(s)
- AIR OPTIX PLUS HYDRAGLYDE Contact Lenses (-12.00 D to -0.25 D, +0.25 D to + 8.00 D); (pack of 1, 3 and 6)
- Model Identifier(s)
- LFB110e
About this record
Access comprehensive regulatory information for Alcon Air Optix Plus Hydraglyde Contact Lenses in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0018378 and owned by ALCON LABORATORIES INC. The device was registered on July 19, 2016.
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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