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FDA 510(k)

LipiFlow Thermal Pulsation System

K-Number: K161357 · 2016-11-04

ApplicantTearscience, Inc.
Decision Date2016-11-04
Product CodeORZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

LipiFlow Thermal Pulsation System is the device name listed in this FDA 510(k) record. The listed applicant is Tearscience, Inc.. It received FDA 510(k) clearance on 2016-11-04 under 510(k) number K161357. 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 LipiFlow Thermal Pulsation System?

LipiFlow Thermal Pulsation System is a medical device that received FDA 510(k) clearance on 2016-11-04. The listed applicant is Tearscience, Inc.. The 510(k) number is K161357.

When did LipiFlow Thermal Pulsation System receive FDA 510(k) clearance?

LipiFlow Thermal Pulsation System received FDA 510(k) clearance on 2016-11-04, under 510(k) number K161357.

Who is the listed applicant for LipiFlow Thermal Pulsation System?

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

What is the FDA product code for LipiFlow Thermal Pulsation System?

The FDA product code for LipiFlow Thermal Pulsation System is ORZ.

Other records listing Tearscience, 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.

K192623LipiFlow Thermal Pulsation SystemK182506LipiScan Dynamic Meibomian ImagerK152869LipiView II Ocular Surface Interferometer

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.

K252409TearCare MGX SystemSight Sciences, Inc.K242786TearCare MGX SystemSight Sciences, Inc.K240512Tixel i (TXLI0001)Novoxel , Ltd.K231084TearCare MGX SystemSight Sciences, Inc.K213045TearCare SystemSight Sciences, Inc.K200400Systane iLux2Tear Film Innovations, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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