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Data / Medical devices / South Korea / Huvitz Co., Ltd.

Huvitz Co., Ltd.: FDA-registered device maker in Anyang-si Gyeonggi, South Korea, 6 510(k) clearances

Huvitz Co., Ltd. is registered with the FDA (registration 9616199) in Anyang-si Gyeonggi, South Korea. It lists 15 device types. The FDA files 6 510(k) clearances under its listings, the newest dated October 23, 2023. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch Huvitz Co., Ltd.
FDA registration number
9616199
FEI number
3003768492
Address
38, Burim-ro 170beon-gil, Dongan-gu, Anyang-si Gyeonggi, South Korea, 14055
Owner or operator
HUVITZ CO., LTD. (9039310)
Roles
Contract manufacturer, Manufacturer, Repackager or relabeler
First device listed
October 14, 1999
Registered through
2027
Brand names listed
Applanation Tonometer, HT-5000, Auto Ref-Topographer, HRKT-1, Biomicroscope, slit-lamp, ac-powered, CIT-4000, Chart, visual acuity, Corneal Topographer, HTG-1, ERK-9100, Fundus Camera HFC-1 and more

Devices it lists

DeviceProduct codeClassRoleSource
Biomicroscope, Slit-Lamp, Ac-PoweredHJO2Contract manufacturer, Manufactureraccessdata.fda.gov
Camera, Ophthalmic, Ac-PoweredHKI2Manufactureraccessdata.fda.gov
Chart, Visual AcuityHOX1Manufactureraccessdata.fda.gov
Instrument, Measuring, Lens, Ac-PoweredHLM1Manufactureraccessdata.fda.gov
Perimeter, Automatic, Ac-PoweredHPT1Repackager or relabeleraccessdata.fda.gov
Projector, OphthalmicHOS1Manufactureraccessdata.fda.gov
Refractometer, OphthalmicHKO1Manufactureraccessdata.fda.gov
Refractor, Manual, Non-Powered, Including PhoropterHKN1Manufactureraccessdata.fda.gov
System, Image Management, OphthalmicNFJ2Manufactureraccessdata.fda.gov
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental RestorationsNOF2Manufactureraccessdata.fda.gov
Table, Instrument, Powered, OphthalmicHRJ1Manufactureraccessdata.fda.gov
Tomography, Optical CoherenceOBO2Manufactureraccessdata.fda.gov
Tonometer, Ac-PoweredHKX2Manufactureraccessdata.fda.gov
Tonometer, ManualHKY2Manufactureraccessdata.fda.gov
Topographer, Corneal, Ac-PoweredMMQ1Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
October 23, 2023K232143Applanation Tonometer HT-5000HKYSubstantially EquivalentHuvitz Co., Ltd.accessdata.fda.gov
February 2, 2021K202097Fundus CameraHKISubstantially EquivalentHuvitz Co., Ltd.accessdata.fda.gov
July 18, 2019K191615Huvitz Imaging SystemNFJSubstantially EquivalentHuvitz Co., Ltd.accessdata.fda.gov
April 6, 2017K161829Huvitz Imaging SystemNFJSubstantially EquivalentHuvitz Co., Ltd.accessdata.fda.gov
December 3, 2009K093639SLIT LAMP, MODELS HS-5000, HS-5500 AND HS-7500HJOSubstantially EquivalentHuvitz Co., Ltd.accessdata.fda.gov
January 11, 2008K073190SLIT LAMPHJOSubstantially EquivalentHuvitz Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated October 23, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.