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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Sight Sciences, Inc.. It received FDA 510(k) clearance on 2026-04-27 under 510(k) 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. The listed applicant is Sight Sciences, Inc.. The 510(k) number is K252409.

When did TearCare MGX System receive FDA 510(k) clearance?

TearCare MGX System received FDA 510(k) clearance on 2026-04-27, under 510(k) number K252409.

Who is the listed applicant for TearCare MGX System?

The FDA 510(k) record lists Sight Sciences, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TearCare MGX System?

The FDA product code for TearCare MGX System is ORZ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07365735TearCare MGX™ System With and Without Warming HoldCOMPLETEDNCT06948773A Study of the Helix Surgical System in Primary Open-Angle Glaucoma (POAG) and Cataract (HELIX)ACTIVE_NOT_RECRUITING

Other records listing Sight Sciences, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253760OMNI Ultra Surgical System (1-110)K242786TearCare MGX SystemK231084TearCare MGX SystemK232214OMNI Surgical SystemK213045TearCare SystemK202678OMNI Surgical System

View all 10 devices →

Related Devices (Code: ORZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242786TearCare MGX SystemSight Sciences, Inc.K240512Tixel i (TXLI0001)Novoxel , Ltd.K231084TearCare MGX SystemSight Sciences, Inc.K213045TearCare SystemSight Sciences, Inc.K200400Systane iLux2Tear Film Innovations, Inc.K192623LipiFlow Thermal Pulsation SystemTearscience, 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.

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