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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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