Data / Medical devices / United States / TearScience, Inc.

TearScience, Inc.: FDA-registered device maker in Milpitas, CA, United States, 4 510(k) clearances

Name: TearScience, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

TearScience, Inc. is registered with the FDA (registration 3008169506) in Milpitas, CA, United States. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated October 22, 2019. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3008169506
Address: 510 Cottonwood Drive, Milpitas, CA, United States, 95035
Owner or operator: Johnson & Johnson Surgical Vision, Inc. (10053607)
Roles: Manufacturer, Specification developer
First device listed: November 18, 2018
Registered through: 2026
Brand names listed: Meibomian Gland Evaluator

Devices it lists

Device	Product code	Class	Role	Source
Biomicroscope, Slit-Lamp, Ac-Powered	HJO	2	Manufacturer, Specification developer	accessdata.fda.gov
Caliper, Ophthalmic	HOE	1	Manufacturer, Specification developer	accessdata.fda.gov
Camera, Ophthalmic, Ac-Powered	HKI	2	Manufacturer, Specification developer	accessdata.fda.gov
Eyelid Thermal Pulsation System	ORZ	2	Manufacturer, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 22, 2019	K192623	LipiFlow Thermal Pulsation System	ORZ	Substantially Equivalent	Tearscience, Inc.	accessdata.fda.gov
December 10, 2018	K182506	LipiScan Dynamic Meibomian Imager	HKI	Substantially Equivalent	Tearscience, Inc.	accessdata.fda.gov
November 4, 2016	K161357	LipiFlow Thermal Pulsation System	ORZ	Substantially Equivalent	Tearscience, Inc.	accessdata.fda.gov
January 14, 2016	K152869	LipiView II Ocular Surface Interferometer	HKI	Substantially Equivalent	Tearscience, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
January 30, 2017	76365	Class II	Terminated	LipiFlow Thermal Pulsation System/LipiFlow, System Activator (Disposable), Rx Only, Sterile	Labeling: The labeled storage temperature is not consistent with the temperature conditions tested for the entire four year shelf life duration.	accessdata.fda.gov
September 13, 2016	75163	Class II	Terminated	LipiFlow thermal Pulsation System, consisting of Console and Activator, Model LFD-1100 The LipiFlow Thermal Pulsation System is intended for use by physicians as a prescription device for the application of localized hea	Complaints related to an error condition occurring during patient treatment where the FipiFlow System automatically stopped treatment after detecting a problem with the Activator.	accessdata.fda.gov

Compare with other makers

Updated October 22, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.