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510(k) K200400

Device
Systane ILux2
Applicant
Tear Film Innovations, Inc.
510(k) number
K200400
Product code
ORZ  
Decision
Substantially Equivalent (SESE)
Decision date
2020-05-21
Date received
2020-02-18
Regulation
886.5200
Classification name
Eyelid Thermal Pulsation System
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Neal Hartman
Address
5924 Balfour Ct., Suite 100 Carlsbad CA US 92008 92008

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code ORZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252409TearCare MGX SystemSight Sciences, Inc.2026-04-27
K242786TearCare MGX SystemSight Sciences, Inc.2025-04-15
K240512Tixel i (TXLI0001)Novoxel , Ltd.2024-11-04
K231084TearCare MGX SystemSight Sciences, Inc.2023-12-27
K213045TearCare SystemSight Sciences, Inc.2021-12-21
K192623LipiFlow Thermal Pulsation SystemTearscience, Inc.2019-10-22
K172645iLux Instrument, iLux DisposableTear Film Innovations, Inc.2017-12-26
K161357LipiFlow Thermal Pulsation SystemTearscience, Inc.2016-11-04
K133127LIPIFLOW THERMAL PULSATION SYSTEMTearscience, Inc.2013-12-23
K112704LIPIFLOW THERMAL PULSATION SYSTEMTearscience, Inc.2011-12-19
DEN100017LIPFLOW THERMAL PULSATION SYSTEM (FORMERLY MANUAL MINI SYSTEM)Tearscience, Inc.2011-06-28

Legacy Summary#

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FDA Review#

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