TOPCON CORPORATION

TOPCON CORPORATION

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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

Chart, Visual Acuity (HOX) (2) Camera, ophthalmic, ac-powered (HKI) (1)

Premarket Exempt

No Yes

Clear

MIRROR CHART MC-5S for COMPU VISION CV-5000 - 04571130283060 Catalog Number :

Device Class : 1

Duns Number: 690542881

Premarket Exempt : Yes

Product Code : HOX

Prescription Use : Yes

Device Count : 1

PIXELCHART PC-50S for COMPU VISION CV-5000 - 04571130283084 Catalog Number :

Device Class : 1

Duns Number: 690542881

Premarket Exempt : Yes

Product Code : HOX

Prescription Use : Yes

Device Count : 1

NON-MYDRIATIC RETINAL CAMERA NW500 - 04571130283152 Catalog Number :

Device Class : 2

Duns Number: 690542881

Premarket Exempt : No

Product Code : HKI

Prescription Use : Yes

Device Count : 1

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