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Singapore HSA registration DE0502170

TearScience LipiFlow Thermal Pulsation System

Singapore flagSingapore·CLASS B·TearScience, Inc.·Registered September 18, 2018
Device classification
Device Class
CLASS B
Medical Speciality Area
Ophthalmology
Registration information
Registration Number
DE0502170
Registration Date
September 18, 2018
Change Notification Approval Date
January 17, 2025
Retention Due Date
September 17, 2025
Product description
The LipiFlow System is intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye.
Product Owner
Name
TearScience, Inc.
Short Name
TearScience, Inc.
Address
510 Cottonwood Drive, Milpitas, California 95035, UNITED STATES
Registrant
Name
AMO SINGAPORE PTE. LIMITED
Address
2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222
Importer
Name
AMO SINGAPORE PTE. LIMITED
Address
2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222
Model information
Model Name(s)
LipiFlow System Cable Kit LipiFlow System Activator (Disposable) LipiFlow System Activator (Disposable) LipiFlow System Activator II (Disposable) TearScience Activator Clear (Disposable) LipiFlow System Console
Model Identifier(s)
CBL-2000 LFD-1000 LFD-1100 LFD-2000 LFD-2100 LFTP-1000
About this record

Access comprehensive regulatory information for TearScience LipiFlow Thermal Pulsation System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0502170 and owned by TearScience, Inc.. The device was registered on September 18, 2018.

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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