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TearScience LipiView II Ocular Surface Interferometer - HSA Registration DE0505341

Access comprehensive regulatory information for TearScience LipiView II Ocular Surface Interferometer in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0505341 and owned by TearScience, Inc.. The device was registered on January 12, 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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CLASS B
DE0505341
TearScience LipiView II Ocular Surface Interferometer
HSA Registration Number: DE0505341
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Product Description

The LipiView II Ocular Surface Interferometer is an ophthalmic imaging device intended for use by a physician in adult patients to capture, archive, manipulate and store digital images of: โ€ข Specular (interferometric) observations of the tear film. Using these images, LipiView II measures the absolute thickness of the tear film lipid layer. โ€ข Meibomian glands under near-infrared (NIR) illumination โ€ข The ocular surface and eyelids under white illumination All of these image types can be photographically documented and visually monitored.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Ophthalmology
Registration Information
Registration Number
DE0505341
Registration Date
January 12, 2021
Change Notification Approval Date
January 17, 2025
Retention Due Date
January 11, 2026
Product Owner
Short Name
TearScience, Inc.
Address
510 Cottonwood Drive, Milpitas, California 95035, UNITED STATES
Registrant
Address
2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222
Importer
Address
2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222
Model Information
Model Name(s)
LipiView II Ocular Surface Interferometer
Model Identifier(s)
LVI-2000