Huvitz Co., Ltd.

Address:38, Burim-ro 170beon-gil, Dongan-gu,Anyang-si Gyeonggi,KR

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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) (1) Refractometer, Ophthalmic (HKO) (1) Tomography, Optical Coherence (OBO) (1)

Premarket Exempt

No Yes

Clear

Ref-Keratometer HRK-1 - 08800019600480 Catalog Number : HRK-1

Device Description : The Ref/Keratometer is intended to be used to measure the refractive power of the eye

Device Class : 1

Duns Number: 688154202

Premarket Exempt : Yes

Product Code : HKO

Prescription Use : No

Device Count : 1

Optical Coherence Tomography HOCT-1F - 08800019600497 Catalog Number : HOCT-1F

Device Description : It is intended for use as a diagnostic device to aid in the check and management It is intended for use as a diagnostic device to aid in the check and management of ocular diseases such as macular holes, cystoid macular edema, diabetic retinopathy, aged related macular degeneration, and so on

Device Class : 2

Duns Number: 688154202

Premarket Exempt : Yes

Product Code : OBO

Prescription Use : No

Device Count : 1

Fundus Camera HFC-1 - 08800019600541 Catalog Number : HFC-1

Device Description : HFC-1 fundus camera is intended to capture digital images for the anterior and r HFC-1 fundus camera is intended to capture digital images for the anterior and retina segment of the eye without the use of a mydriatic agent. It is intended for use as an aid to clinicians in the evaluation and diagnosis of ocular health.

Device Class : 2

Duns Number: 688154202

Premarket Exempt : No

Product Code : HKI

Prescription Use : No

Device Count : 1

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