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TEARSCIENCE, INC.

United States·US-MF-000014446

Last updated September 17, 2026

Information

Device	Model / Reference	Registries	Class	Status
Tearscience Activator Clear (disposable)	0803-5050	EUDAMED	Class IIa	Active
Ref-240150	REF-240150	EUDAMED	Class I	Active
Lipiview Ii Ocular Surface Interferomete	LVI-2000	FDA UDI	Class II	Active
Lipiflow System Activator (disposable)	LFD-1100	FDA UDI	Class II	Unknown
Meibomian Gland Evaluator	DMI-1000	FDA UDI	Class II	Active
Lipiview Ocular Surface Interferometer	LVI-1001	FDA UDI	Class II	Active
Lipiflow System Activator Ii (disposable	LFD-2000	FDA UDI	Class II	Active
Lipiflow System Console	LFTP-1000	FDA UDI	Class II	Active
Lipiflow System Activator (disposable)	LFD-1000	FDA UDI	Class II	Unknown
Meibomian Gland Evaluator	MGE-1000	FDA UDI	Class I	Active
Lipiflow System Activator Ii Cable Kit	CBL-2000	EUDAMEDFDA UDI	Class II	Active
Meibomian Gland Evaluator	MGE-1001	FDA UDI	Class I	Active
LipiView II Ocular Surface Interferometer	K152869	FDA 510(k)	Class II	Active
LipiFlow Thermal Pulsation System	K161357	FDA 510(k)	Class II	Active
Lipiview Ocular Surface Interferometer	K091935	FDA 510(k)	Class II	Active
Lipiflow Thermal Pulsation System	K112704	FDA 510(k)	Class II	Active
Lipiview Ocular Surface Interferometer	K122481	FDA 510(k)	Class II	Active
Lipiflow Thermal Pulsation System	K133127	FDA 510(k)	Class II	Active
LipiFlow Thermal Pulsation System	K192623	FDA 510(k)	Class II	Active
LipiScan Dynamic Meibomian Imager	K182506	FDA 510(k)	Class II	Active
Lipflow Thermal Pulsation System (formerly Manual Mini System)	DEN100017	FDA 510(k)	Class II	Active

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Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jan 30, 2017	Z-1535-2017	—	terminated	Labeling: The labeled storage temperature is not consistent with the temperature conditions tested for the entire four year shelf life duration.
Sep 13, 2016	Z-0093-2017	—	terminated	Complaints related to an error condition occurring during patient treatment where the FipiFlow System automatically stopped treatment after detecting a problem with the Activator.