TearCare System
K-Number: K213045 · 2021-12-21
ApplicantSight Sciences, Inc.
Decision Date2021-12-21
Product CodeORZ
Advisory CommitteeOP
DecisionSubstantially Equivalent
Device Summary
TearCare System is a medical device manufactured by Sight Sciences, Inc.. It received FDA 510(k) clearance on 2021-12-21 under approval number K213045. The device is classified under product code ORZ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the TearCare System?
TearCare System is a medical device that received FDA 510(k) clearance on 2021-12-21. It is manufactured by Sight Sciences, Inc.. The 510(k) number is K213045.
When was TearCare System approved by the FDA?
TearCare System received FDA 510(k) clearance on 2021-12-21, under approval number K213045.
What company makes TearCare System?
TearCare System is manufactured by Sight Sciences, Inc..
What is the FDA product code for TearCare System?
The FDA product code for TearCare System is ORZ.
Related Clinical Trials
Other Devices by Sight Sciences, Inc.
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K200400Systane iLux2Tear Film Innovations, Inc.
K231084TearCare MGX SystemSight Sciences, Inc.
K240512Tixel i (TXLI0001)Novoxel , Ltd.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.