Singapore HSA registration DE0505341
TearScience LipiView II Ocular Surface Interferometer
Singapore·CLASS B·TearScience, Inc.·Registered January 12, 2021Device 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 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: • Specular (interferometric) observations of the tear film. Using these images, LipiView II measures the absolute thickness of the tear film lipid layer. • Meibomian glands under near-infrared (NIR) illumination • The ocular surface and eyelids under white illumination All of these image types can be photographically documented and visually monitored.
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
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B