KOWA COMPANY,LTD.

Want to know more about this Organization? Request more information now!

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

Camera, Ophthalmic, Ac-Powered (HKI) (5) Biomicroscope, Slit-Lamp, Ac-Powered (HJO) (1) Ophthalmoscope,Laser,Scanning (MYC) (1) Perimeter, Automatic, Ac-Powered (HPT) (1) Tonometer, Ac-Powered (HKX) (1) Tonometer, Manual (HKY) (1)

Premarket Exempt

No Yes

Clear

KOWA GENESIS-Df - 04987646800583 Catalog Number :

Device Description : KOWA GENESIS-Df is a device intended to capture and save fundus images with mydriatic.

Device Class : 2

Duns Number: 692281073

Premarket Exempt : No

Product Code : HKI

Prescription Use : Yes

Device Count : 1

KOWA nonmyd a-DIII - 04987646800606 Catalog Number :

Device Description : KOWA nonmyd a-DIII, fundus camera, is intended for use with retinal image captur KOWA nonmyd a-DIII, fundus camera, is intended for use with retinal image capturing without mydriatic. The retinal image can be stored to an image filing drive through serial interface.

Device Class : 2

Duns Number: 692281073

Premarket Exempt : No

Product Code : HKI

Prescription Use : Yes

Device Count : 1

KOWA VX-10 - 04987646802006 Catalog Number :

Device Description : KOWA VX-10 is intended for taking pictures of fundus images with mydriatic or wi KOWA VX-10 is intended for taking pictures of fundus images with mydriatic or without mydriatic.

Device Class : 2

Duns Number: 692281073

Premarket Exempt : No

Product Code : HKI

Prescription Use : Yes

Device Count : 1

KOWA Applanation Tonometer HA-2 - 04987646803799 Catalog Number :

Device Description : For the measurement of intraocular pressure in the diagnosis of glaucoma.

Device Class : 2

Duns Number: 692281073

Premarket Exempt : No

Product Code : HKY

Prescription Use : Yes

Device Count : 1

KOWA GENESIS-D - 04987646803973 Catalog Number :

Device Description : The Kowa hand-held retinal camera, KOWA GENESIS-D is a device intended to captur The Kowa hand-held retinal camera, KOWA GENESIS-D is a device intended to capture and save fundus images with mydriatic.

Device Class : 2

Duns Number: 692281073

Premarket Exempt : No

Product Code : HKI

Prescription Use : Yes

Device Count : 1

KOWA FM-600 - 04987646804024 Catalog Number :

Device Description : KOWA FM-600 is an instrument to measure the protein level contained in aqueous h KOWA FM-600 is an instrument to measure the protein level contained in aqueous humor of the anterior chamber of human eye.

Device Class : 2

Duns Number: 692281073

Premarket Exempt : No

Product Code : MYC

Prescription Use : Yes

Device Count : 1

KOWA SL-15 - 04987646804031 Catalog Number :

Device Description : KOWA SL-15 is an ophthalmic device indicated for non-invasive illumination, magn KOWA SL-15 is an ophthalmic device indicated for non-invasive illumination, magnification and observation of the human eye. It consists of a hand-held, battery powered slit-lamp biomicroscope with viewing and illumination optical systems and an AC-powered stand.

Device Class : 2

Duns Number: 692281073

Premarket Exempt : No

Product Code : HJO

Prescription Use : Yes

Device Count : 1

KOWA KT-800 - 04987646804109 Catalog Number :

Device Description : The Kowa KT-800 is indicated for measuring intraocular pressure without contacti The Kowa KT-800 is indicated for measuring intraocular pressure without contacting the eye to aid in the screening and diagnosis of glaucoma.

Device Class : 2

Duns Number: 692281073

Premarket Exempt : No

Product Code : HKX

Prescription Use : Yes

Device Count : 1

KOWA VX-10a - 04987646804147 Catalog Number :

Device Description : KOWA VX-10a is intended for taking pictures of fundus images with mydriatic or w KOWA VX-10a is intended for taking pictures of fundus images with mydriatic or without mydriatic.

Device Class : 2

Duns Number: 692281073

Premarket Exempt : No

Product Code : HKI

Prescription Use : Yes

Device Count : 1

KOWA AP-7000 - 04987646805113 Catalog Number :

Device Description : KOWA AP-7000 is an automatic perimeter to perform perimetry examinations and to KOWA AP-7000 is an automatic perimeter to perform perimetry examinations and to display and output examination results.Static quantitative perimetry examinations and kinetic perimetry examinations are available.

Device Class : 1

Duns Number: 692281073

Premarket Exempt : Yes

Product Code : HPT

Prescription Use : Yes

Device Count : 1

Previous 1 2 3 Next