CLARITY MEDICAL SYSTEMS, INC.

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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) (3)

Premarket Exempt

Clear

RetCam 3 - 00899281002113 Catalog Number :

Device Description : RetCam 3 Ophthalmic Imaging System is designed to allow the quick and easy captu RetCam 3 Ophthalmic Imaging System is designed to allow the quick and easy capture of wide field, high resolution, fully digital images and videos of the eye.

Device Class : 2

Duns Number: 808456037

Premarket Exempt : No

Product Code : HKI

Prescription Use : Yes

Device Count : 1

RetCam Shuttle - 00899281002120 Catalog Number :

Device Description : The RetCam Shuttle Ophthalmic Imaging System is designed to allow the quick and The RetCam Shuttle Ophthalmic Imaging System is designed to allow the quick and easy capture of wide field, high resolution, fully digital images and videos of the eye.

Device Class : 2

Duns Number: 808456037

Premarket Exempt : No

Product Code : HKI

Prescription Use : Yes

Device Count : 1

RetCam Portable - 00899281002137 Catalog Number :

Device Description : The RetCam Portable Ophthalmic Imaging System is designed to allow the quick and The RetCam Portable Ophthalmic Imaging System is designed to allow the quick and easy capture of wide field, high resolution, fully digital images and videos of the eye.

Device Class : 2

Duns Number: 808456037

Premarket Exempt : No

Product Code : HKI

Prescription Use : Yes

Device Count : 1

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