Huvitz Co., Ltd.

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

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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

Refractometer, Ophthalmic (HKO) (4) Chart, Visual Acuity (HOX) (2) Refractor, Manual, Non-Powered, Including Phoropter (HKN) (2) Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System (NVV) (1) Tonometer, Ac-Powered (HKX) (1)

Premarket Exempt

No Yes

Clear

maging System HIS-5000U - 08800019600121 Catalog Number : HIS-5000U

Device Description : imaging system is intended for help observation and recording of eye using a slit lamp

Device Class : 1

Duns Number: 688154202

Premarket Exempt : No

Product Code : NVV

Prescription Use : No

Device Count : 1

Ref/Keratometers HRK-7000 - 08800019600138 Catalog Number : HRK-7000

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

Auto Ref-Keratometer HRK-7000A - 08800019600145 Catalog Number : HRK-7000A

Device Description : The Auto 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

Auto Ref-Keratometer HRK-8000A - 08800019600152 Catalog Number : HRK-8000A

Device Description : The Auto 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

Auto Ref-Keratometer HRK-9000A - 08800019600169 Catalog Number : HRK-9000A

Device Description : The Auto 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

Non-contact Tonometer HNT-7000 - 08800019600176 Catalog Number : HNT-7000

Device Description : The Non-Contact Tonometer is intended to be used to measure the intraocular pres The Non-Contact Tonometer is intended to be used to measure the intraocular pressure of the human eye.

Device Class : 2

Duns Number: 688154202

Premarket Exempt : Yes

Product Code : HKX

Prescription Use : No

Device Count : 1

Digital Chart HDC-7000 - 08800019600183 Catalog Number : HDC-7000

Device Description : Digital Chart is a computerized chart presenting device that provides charts for Digital Chart is a computerized chart presenting device that provides charts for refractive correction test and various functional tests

Device Class : 1

Duns Number: 688154202

Premarket Exempt : Yes

Product Code : HOX

Prescription Use : No

Device Count : 1

Digital Chart HDC-9000 - 08800019600190 Catalog Number : HDC-9000

Device Class : 1

Duns Number: 688154202

Premarket Exempt : Yes

Product Code : HOX

Prescription Use : No

Device Count : 1

Digital Refractor HDR-7000 - 08800019600206 Catalog Number : HDR-7000

Device Description : Digital Refractor system is a computerized auto refractor used for subjective re Digital Refractor system is a computerized auto refractor used for subjective refraction by regarding the patient’s accommodation power and facilities.

Device Class : 1

Duns Number: 688154202

Premarket Exempt : Yes

Product Code : HKN

Prescription Use : No

Device Count : 1

Digital Refractor HDR-9000 - 08800019600213 Catalog Number : HDR-9000

Device Class : 1

Duns Number: 688154202

Premarket Exempt : Yes

Product Code : HKN

Prescription Use : No

Device Count : 1

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