TearCare MGX System
K-Number: K252409 · 2026-04-27
ApplicantSight Sciences, Inc.
Decision Date2026-04-27
Product CodeORZ
Advisory CommitteeOP
DecisionSubstantially Equivalent
Device Summary
TearCare MGX System is a medical device manufactured by Sight Sciences, Inc.. It received FDA 510(k) clearance on 2026-04-27 under approval number K252409. 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 MGX System?
TearCare MGX System is a medical device that received FDA 510(k) clearance on 2026-04-27. It is manufactured by Sight Sciences, Inc.. The 510(k) number is K252409.
When was TearCare MGX System approved by the FDA?
TearCare MGX System received FDA 510(k) clearance on 2026-04-27, under approval number K252409.
What company makes TearCare MGX System?
TearCare MGX System is manufactured by Sight Sciences, Inc..
What is the FDA product code for TearCare MGX System?
The FDA product code for TearCare MGX System is ORZ.
Related Clinical Trials
Other Devices by Sight Sciences, Inc.
Related Devices (Code: ORZ)
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K200400Systane iLux2Tear Film Innovations, Inc.
K213045TearCare SystemSight Sciences, Inc.
K231084TearCare MGX SystemSight Sciences, Inc.
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.