Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

LipiFlow Thermal Pulsation System

K-Number: K192623 · 2019-10-22

ApplicantTearscience, Inc.
Decision Date2019-10-22
Product CodeORZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

LipiFlow Thermal Pulsation System is a medical device manufactured by Tearscience, Inc.. It received FDA 510(k) clearance on 2019-10-22 under approval number K192623. 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 2019-10-22. It is manufactured by Tearscience, Inc.. The 510(k) number is K192623.

When was LipiFlow Thermal Pulsation System approved by the FDA?

LipiFlow Thermal Pulsation System received FDA 510(k) clearance on 2019-10-22, under approval number K192623.

What company makes LipiFlow Thermal Pulsation System?

LipiFlow Thermal Pulsation System is manufactured by Tearscience, Inc..

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

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

Related Clinical Trials

NCT07599592 Open Label Study for the Use of Low Intensity Focused Ultrasound for Essential Tremor RECRUITING NCT06472622 Functional Neuroimaging to Detect the Neural Signatures of the Unpleasantness of Pain and Effort RECRUITING NCT07580560 Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) Abnormal Uterine Bleeding Safety Study COMPLETED NCT03767530 Efficacy and Safety of Thermic Devices in the Treatment of Meibomian Gland Dysfunction RECRUITING NCT07365735 TearCare MGX™ System With and Without Warming Hold ACTIVE_NOT_RECRUITING NCT04305925 Focal Laser Ablation of Prostate Cancer COMPLETED

Other Devices by Tearscience, Inc.

K161357LipiFlow Thermal Pulsation System K152869LipiView II Ocular Surface Interferometer K182506LipiScan Dynamic Meibomian Imager

Related Devices (Code: ORZ)

K161357LipiFlow Thermal Pulsation SystemTearscience, Inc. K172645iLux Instrument, iLux DisposableTear Film Innovations, Inc. K200400Systane iLux2Tear Film Innovations, Inc. K213045TearCare SystemSight Sciences, 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.

↑