KOWA COMPANY,LTD.

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- Catalog Number :

Device Description : KOWA nonmyd WX is intended for use with plane and stereo retinal image capturing KOWA nonmyd WX is intended for use with plane and stereo retinal image capturing without mydriatic. The retina image can be stored to an image filing derive through serial interface.

Device Class : 2

Duns Number: 692281073

Premarket Exempt : No

Product Code : HKI

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : KOWA SL-17 is intended for use in eye examination of the anterior eye segment, f KOWA SL-17 is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.

Device Class : 2

Duns Number: 692281073

Premarket Exempt : No

Product Code : HJO

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : KOWA SL-17 is intended for use in eye examination of the anterior eye segment, f KOWA SL-17 is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.

Device Class : 2

Duns Number: 692281073

Premarket Exempt : No

Product Code : HJO

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : KOWA SL-17 is intended for use in eye examination of the anterior eye segment, f KOWA SL-17 is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.

Device Class : 2

Duns Number: 692281073

Premarket Exempt : No

Product Code : HJO

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : KOWA SL-17 is intended for use in eye examination of the anterior eye segment, f KOWA SL-17 is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.

Device Class : 2

Duns Number: 692281073

Premarket Exempt : No

Product Code : HJO

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : The KOWA VX-20 is intended for taking pictures of retinal images with mydriatic The KOWA VX-20 is intended for taking pictures of retinal images with mydriatic or without mydriatic.

Device Class : 2

Duns Number: 692281073

Premarket Exempt : No

Product Code : HKI

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : KOWA nonmyd 7 is intended for use with retina image capturing without mydriatic. KOWA nonmyd 7 is intended for use with retina image capturing without mydriatic. The retina image can be stored to an image filing equipment through serial interface.

Device Class : 2

Duns Number: 692281073

Premarket Exempt : No

Product Code : HKI

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : The KOWA nonmyd 8 is intended for use with retinal image capturing without mydriatic.

Device Class : 2

Duns Number: 692281073

Premarket Exempt : Yes

Product Code : PJZ

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : The KOWA nonmyd 8s is intended for use with retinal image capturing without mydriatic.

Device Class : 2

Duns Number: 692281073

Premarket Exempt : Yes

Product Code : PJZ

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : The KOWA DR-1α is an ocular surface interferometer, which is an ophthalmic imagi The KOWA DR-1α is an ocular surface interferometer, which is an ophthalmic imaging device that is intended for use by physician in adult patients to observe and record a video image of specular (interferometric) observations of the tear film, which can be visually monitored and photographically documented.

Device Class : 2

Duns Number: 692281073

Premarket Exempt : No

Product Code : HKI

Prescription Use : Yes

Device Count : 1