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Singapore HSA registration DE0507091

Johnson & Johnson ACUVUE Abiliti 1-DAY Soft Therapeutic Lenses for Myopia Management

Singapore flagSingapore·CLASS B·Johnson & Johnson Vision Care, Inc.·Registered July 15, 2022
Device classification
Device Class
CLASS B
Medical Speciality Area
Ophthalmology
Registration information
Registration Number
DE0507091
Registration Date
July 15, 2022
Change Notification Approval Date
August 13, 2024
Retention Due Date
July 14, 2025
Product description
The ACUVUE Abiliti 1-Day Soft Therapeutic Lenses for Myopia Management are intended for daily wear, worn on a daily disposable basis, for the correction of nearsightedness (while the lenses are worn) and to slow the patient’s prescription change over time. The contact lenses are intended to be used by children who, at the initiation of treatment, are 7 to 12 years old, with myopia between -0.75D and -4.50D and 1.00D or less astigmatism, with non-diseased eyes and are symptomatic with regard to a need for distance vision correction.
Product Owner
Name
Johnson & Johnson Vision Care, Inc.
Short Name
Johnson & Johnson Vision Care, Inc.
Address
7500 Centurion Parkway, Jacksonville, Florida 32256, UNITED STATES
Registrant
Name
Johnson & Johnson International (Singapore) Pte Ltd
Address
2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222
Importer
Name
JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD
Address
2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222
Model information
Model Name(s)
ACUVUE Abiliti 1-DAY Soft Therapeutic Lenses for Myopia Management (SPH: -0.25D to -8.00D) (Pack size: 1, 2, 3, 5, 6, 10, 12, 20, 24, 30, 60, 90, 180, 360 lenses) (Trial size: 5 lenses)
Model Identifier(s)
ACUVUE Abiliti 1-DAY Soft Therapeutic Lenses for Myopia Management
About this record

Access comprehensive regulatory information for Johnson & Johnson ACUVUE Abiliti 1-DAY Soft Therapeutic Lenses for Myopia Management in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0507091 and owned by Johnson & Johnson Vision Care, Inc.. The device was registered on July 15, 2022.

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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