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Alcon Total30 (lehfilcon A) Soft Contact Lens - HSA Registration DE0506334

Access comprehensive regulatory information for Alcon Total30 (lehfilcon A) Soft Contact Lens in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0506334 and owned by Alcon Laboratories, Inc.. The device was registered on November 01, 2021.

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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HSA Official Data
CLASS B
DE0506334
Alcon Total30 (lehfilcon A) Soft Contact Lens
HSA Registration Number: DE0506334
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Product Description

TOTAL30 (lehfilcon A) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic (having the natural eye lens) or aphakic (not having the natural eye lens) 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 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
DE0506334
Registration Date
November 01, 2021
Change Notification Approval Date
March 30, 2023
Retention Due Date
October 31, 2025
Product Owner
Short Name
Alcon
Address
6201 South Freeway, For 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)
TOTAL30 ONE-MONTH REPLACEMENT CONTACT LENSES -0.25 to -8.00 D (0.25 D steps); -8.50 to -12.00 D (0.50 D steps); +0.25 to +6.00 D (0.25 D steps); +6.50 to +8.00D (0.50 D steps) Pack of 6 (Trade) TOTAL30 ONE-MONTH REPLACEMENT CONTACT LENSES -0.25 to -8.00 D (0.25 D steps); -8.50 to -12.00 D (0.50 D steps); +0.25 to +6.00 D (0.25 D steps); +6.50 to +8.00D (0.50 D steps) Pack of 3 (Trade) TOTAL30 ONE-MONTH REPLACEMENT CONTACT LENSES -0.25 to -8.00 D (0.25 D steps); -8.50 to -12.00 D (0.50 D steps); +0.25 to +6.00 D (0.25 D steps); +6.50 to +8.00D (0.50 D steps) Pack of 3 (Trial) TOTAL30 ONE-MONTH REPLACEMENT CONTACT LENSES -0.25 to -8.00 D (0.25 D steps); -8.50 to -12.00 D (0.50 D steps); +0.25 to +6.00 D (0.25 D steps); +6.50 to +8.00D (0.50 D steps) Pack of 1 (Trial)
Model Identifier(s)
EVCHA01 EVCHA02 EVCHA03 EVCHA04