TEARSCIENCE, INC.

Address:510 Cottonwood Drive,Milpitas,CA,95035,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Eyelid thermal pulsation system (ORZ) (5) Camera, ophthalmic, ac-powered (HKI) (3) Biomicroscope, slit-lamp, ac-powered (HJO) (2) Caliper, ophthalmic (HOE) (2)

Premarket Exempt

No Yes

Clear

MEIBOMIAN GLAND EVALUATOR - 00859623006001 Catalog Number : 300000

Device Description : MEIBOMIAN GLAND EVALUATOR - GBL

Device Class : 1

Duns Number: 791626901

Premarket Exempt : Yes

Product Code : HOE

Prescription Use : Yes

Device Count : 1

MEIBOMIAN GLAND EVALUATOR - 00859623006018 Catalog Number : 300001

Device Description : MEIBOMIAN GLAND EVALUATOR - AU,CA,US

Device Class : 1

Duns Number: 791626901

Premarket Exempt : Yes

Product Code : HOE

Prescription Use : Yes

Device Count : 1

LIPIFLOW SYSTEM ACTIVATOR (DISPOSABLE) - 00859623006117 Catalog Number : 221000

Device Description : ACTIVATORS (BOX OF 10) US

Device Class : 2

Duns Number: 791626901

Premarket Exempt : No

Product Code : ORZ

Prescription Use : Yes

Device Count : 1

LIPIFLOW SYSTEM ACTIVATOR (DISPOSABLE) - 00859623006216 Catalog Number : 221001

Device Description : ACTIVATORS (BOX OF 10) US

Device Class :

Duns Number: 791626901

Premarket Exempt : No

Product Code : ORZ

Prescription Use : Yes

Device Count : 1

LIPIFLOW SYSTEM ACTIVATOR II (DISPOSABLE - 00859623006315 Catalog Number : 221050

Device Description : ACTIVATORS (BOX OF 10) US

Device Class : 2

Duns Number: 791626901

Premarket Exempt : No

Product Code : ORZ

Prescription Use : Yes

Device Count : 1

LIPIFLOW SYSTEM CONSOLE - 00859623006414 Catalog Number : 210000

Device Description : ASSEMBLY PKGD LIPIFLOW - US

Device Class : 2

Duns Number: 791626901

Premarket Exempt : No

Product Code : ORZ

Prescription Use : Yes

Device Count : 1

LIPIVIEW OCULAR SURFACE INTERFEROMETER - 00859623006513 Catalog Number : 100000

Device Description : ASSEMBLY PKGD LIPIVIEW 1 - INTL

Device Class : 2

Duns Number: 791626901

Premarket Exempt : No

Product Code : HKI, HJO

Prescription Use : Yes

Device Count : 1

LIPIVIEW II OCULAR SURFACE INTERFEROMETE - 00859623006612 Catalog Number : 100100

Device Description : ASSEMBLY PKGD LIPIVIEW-2 - US

Device Class : 2

Duns Number: 791626901

Premarket Exempt : No

Product Code : HKI, HJO

Prescription Use : Yes

Device Count : 1

LIPIFLOW SYSTEM ACTIVATOR II CABLE KIT - 00859623006711 Catalog Number : 240100

Device Description : KIT CABLE PKGD ACTIVATOR II - US

Device Class : 2

Duns Number: 791626901

Premarket Exempt : No

Product Code : ORZ

Prescription Use : Yes

Device Count : 1

MEIBOMIAN GLAND EVALUATOR - 00859623006919 Catalog Number : 400000

Device Description : ASSEMBLY PKGD LIPISCAN - US

Device Class : 2

Duns Number: 791626901

Premarket Exempt : No

Product Code : HKI

Prescription Use : Yes

Device Count : 1

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