FDA 510(k) Applications for Medical Device Product Code "ORZ"

FDA 510(k) Number Applicant Device Name Decision Date
K213045 Sight Sciences, Inc. TearCare System 12/21/2021
K172645 Tear Film Innovations, Inc. iLux Instrument, iLux Disposable 12/26/2017
K200400 Tear Film Innovations, Inc. Systane iLux2 05/21/2020
K192623 TearScience Inc. LipiFlow Thermal Pulsation System 10/22/2019
DEN100017 TEARSCIENCE, INC. LIPFLOW THERMAL PULSATION SYSTEM (FORMERLY MANUAL MINI SYSTEM) 06/28/2011
K112704 TEARSCIENCE, INC. LIPIFLOW THERMAL PULSATION SYSTEM 12/19/2011
K133127 TEARSCIENCE, INC. LIPIFLOW THERMAL PULSATION SYSTEM 12/23/2013
K161357 TEARSCIENCE, INC. LipiFlow Thermal Pulsation System 11/04/2016


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