Eyelid Thermal Pulsation System
Ophthalmic · 21 CFR 886.5200
Therapeutic application of heat and massage to the eyelids.
Recent MDR events
37 adverse event reports on file
- TEARCAREJan 2, 2025InjurySight Sciences, Inc.MW5164267
- UNKNOWN ILUX SYSTEM DEVICEJun 28, 2024InjuryAlcon Research, Llc - Irvine Technology Center2028159-2024-00940
- TEARCARE SYSTEMMay 28, 2024InjurySight Sciences Inc.3010363671-2024-00006
- UNKNOWN ILUX SYSTEM DEVICEMar 19, 2024InjuryAlcon Research, Llc - Irvine Technology Center2028159-2024-00437
- LIPIFLOWAug 16, 2023InjuryUnknownMW5144694
- LIPIFLOW SYSTEM ACTIVATOR II (DISPOSABLE)Aug 2, 2023InjuryTearscience, Inc.3012236936-2023-01995
- LIPIFLOW SYSTEM ACTIVATOR II (DISPOSABLEAug 2, 2023InjuryTearscience, Inc.3012236936-2023-01996
- SYSTANE ILUX2 MGD THERMAL PULSATION SYSTEMMay 11, 2023InjuryAlcon Research, Llc - Irvine Technology Center2028159-2023-00677
- SYSTANE ILUX2 MGD THERMAL PULSATION SYSTEMApr 19, 2023InjuryAlcon Research, Llc - Irvine Technology Center2028159-2023-00565
- SYSTANE ILUX2 MGD THERMAL PULSATION SYSTEMApr 11, 2023InjuryAlcon Research, Llc - Irvine Technology Center2028159-2023-00482
Event type breakdown
Recalls
3 recall events for this product code
- Tearscience, IncTerminatedMar 22, 2017
LipiFlow Thermal Pulsation System/LipiFlow, System Activator (Disposable), Rx Only, Sterile
Labeling: The labeled storage temperature is not consistent with the temperature conditions tested for the entire four year shelf life duration.
Z-1535-2017 · View FDA record ↗ - Tearscience, IncTerminatedOct 17, 2016
LipiFlow thermal Pulsation System, consisting of Console and Activator, Model LFD-1100
Complaints related to an error condition occurring during patient treatment where the FipiFlow System automatically stopped treatment after detecting a problem with the Activator.
Z-0093-2017 · View FDA record ↗ - Sight Sciences, Inc.Open, ClassifiedUnknown
TearCare version 1.0 SmartHubs
Ophthalmic devices distributed prior to the recently-obtained 510(k) clearance do not fall within the relevant 510(k) exemption and so their performance characteristics were not evaluated by the FDA prior to distribution.
Z-1001-2022 · View FDA record ↗
Registered firms
35 firms currently registered for this product code
Peter's Technology (suzhou) Co., Ltd.
Suzhou Jiangsu, CN
Sterigenics U.s., Llc
Haw River, NC, US
Sight Sciences, Inc.
Menlo Park, CA, US
Alcon Research, Llc
Fort Worth, TX, US
Remington Medical, Inc.
Alpharetta, GA, US
Shenzhen Jpy Ion-tech. Co., Ltd.
Shenzhen Guangdong, CN
Tearscience, Inc.
Milpitas, CA, US
Mme Willow Lake
Vadnais Hts, MN, US
Alcon Research, Llc
IRVINE, CA, US
Isomedix Operations, Inc.
Minneapolis, MN, US
Evolve Manufacturing Technologies Inc.
Fremont, CA, US
Remington Medical, Inc.
ALPHARETTA, GA, US
Remington Medical, S.a.
Santo Domingo Este, DO
Segue Xiamen Manufacturing Services, Inc
Xiamen Fujian, CN
510(k) clearances
12 clearances for this product code
- Sight Sciences, Inc.Apr 27, 2026
K252409 · TearCare MGX System
- Sight Sciences, Inc.Apr 15, 2025
K242786 · TearCare MGX System
- Novoxel , Ltd.Nov 4, 2024
K240512 · Tixel i (TXLI0001)
- Sight Sciences, Inc.Dec 27, 2023
K231084 · TearCare MGX System
- Sight Sciences, Inc.Dec 21, 2021
K213045 · TearCare System
- Tear Film Innovations, Inc.May 21, 2020
K200400 · Systane iLux2
- Tearscience, Inc.Oct 22, 2019
K192623 · LipiFlow Thermal Pulsation System
- Tear Film Innovations, Inc.Dec 26, 2017
K172645 · iLux Instrument, iLux Disposable