Singapore HSA registration DE0506334

Alcon Total30 (lehfilcon A) Soft Contact Lens

Singapore·CLASS B·Alcon Laboratories, Inc.·Registered November 01, 2021

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 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.

Product Owner

Name: Alcon Laboratories, Inc.
Short Name: Alcon
Address: 6201 South Freeway, For Worth, Texas 76134-2099, UNITED STATES

Registrant

Name: ALCON PTE LTD
Address: 1 FUSIONOPOLIS WALK, SOLARIS, #08-02, SINGAPORE 138628

Importer

Name: ALCON PTE LTD DKSH SINGAPORE PTE. LTD.
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

About this record

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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