HUVITZ CO., LTD.

FDA Device Registration & Listing · Anyang-si Gyeonggi, KR · Registration 9616199

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9616199
FEI Number
3003768492
Entity Name
HUVITZ CO., LTD.
City/State/Country
Anyang-si Gyeonggi, KR
Establishment Address
38, Burim-ro 170beon-gil, Dongan-gu, Anyang-si Gyeonggi 14055, KR
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
HUVITZ CO., LTD. (Owner Number: 9039310)
Owner / Operator Contact Address
38, Burim-ro 170beon-gil, Dongan-gu, Anyang-si, KR-41 14055, KR
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Refractor, manual, non-powered, including phoropter HDR-7000 HDR-9000 HDR-7000P HDR-7100P Optical Biometer, HBM-1 Chart, visual acuity HDC-9100PF HDC-9100N HDC-7000 HDC-100 Tomography, optical coherence(HOCT-1, HOCT-1F) Biomicroscope, slit-lamp, ac-powered HS-7500 HS-5500 HS-7000 Lilivis CAD L-CAD OCTiX IntraOral Scanner LSO-100 LS-100-TIP-3R Lilivis Scan LS-100 Biomicroscope, slit-lamp, ac-powered K073190 Integrated image server;HIIS-1 Tonometer, ac-powered HNT-1 HNT-1P HTR-1A Projector, ophthalmic HCP-7000 ERK-9100 HRK-8000A HRK-7000A HRK-9000A HRK-1 HRK-8100A Vision Screener, HVS-1 Applanation Tonometer, HT-5000 System, image management, ophthalmic Fundus Camera HFC-1 Instrument, measuring, lens, ac-powered HLM-1 HLM-9000 HLM-7000P HVF-100 System, image management, ophthalmic HIS-5000U( (10M, 5M, 1.4M) topographer, corneal Corneal Topographer, HTG-1 Auto Ref-Topographer, HRKT-1

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HKN Refractor, Manual, Non-Powered, Including Phoropter Ophthalmic Class 1 886.1770 1999-10-14
HJO Biomicroscope, Slit-Lamp, Ac-Powered Ophthalmic Class 2 886.1850 2023-10-10
HOX Chart, Visual Acuity Ophthalmic Class 1 886.1150 2011-12-15
OBO Tomography, Optical Coherence Ophthalmic Class 2 886.1570 2018-02-11
HJO Biomicroscope, Slit-Lamp, Ac-Powered Ophthalmic Class 2 886.1850 2010-03-11
NOF System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations Dental Class 2 872.3661 2024-05-23
HJO Biomicroscope, Slit-Lamp, Ac-Powered Ophthalmic Class 2 886.1850 2008-01-20
NFJ System, Image Management, Ophthalmic Radiology Class 2 892.2050 2025-08-12
HKX Tonometer, Ac-Powered Ophthalmic Class 2 886.1930 2016-08-10
HOS Projector, Ophthalmic Ophthalmic Class 1 886.1680 2001-03-29
HKO Refractometer, Ophthalmic Ophthalmic Class 1 886.1760 2001-04-03
HKY Tonometer, Manual Ophthalmic Class 2 886.1930 2023-10-24
NFJ System, Image Management, Ophthalmic Radiology Class 2 892.2050 2019-05-12
HKI Camera, Ophthalmic, Ac-Powered Ophthalmic Class 2 886.1120 2021-02-02
HLM Instrument, Measuring, Lens, Ac-Powered Ophthalmic Class 1 886.1425 2001-03-29
HPT Perimeter, Automatic, Ac-Powered Ophthalmic Class 1 886.1605 2022-06-10
NFJ System, Image Management, Ophthalmic Radiology Class 2 892.2050 2019-07-18
MMQ Topographer, Corneal, Ac-Powered Ophthalmic Class 1 886.1350 2021-02-02

Official Correspondent

Hyung Min Heo

US Agent Details

Dave Kim Business: Mtech Group LLC Email: davekim@mtechgroupllc.com Phone: (713) 4672607

Related Public Records

Same Entity

HUVITZ CO., LTD.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K870750 Keeler Instruments, Inc. KEELER PULSAIR NON CONTACT TONOMETER 1987-03-17
K041546 Canon, Inc. DIGITAL FUNDUS CAMERA, MODEL CF-60DSI 2004-06-23

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0024-2013 Optovue Inc. 2
Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100; The physical Product is manufactured and distributed by Optovue, Inc. Fremont, CA The product is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an aid in the diagnosis and management of retinal disease.
Z-0009-2018 Optovue, Inc. 2
iFusion, Device Listing Number D203271. Product Usage: The iCam is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying and storing images of the retina and external areas of the eye to be evaluated under non-mydriatic conditions. The iCam takes digital images of the posterior and external structures of the eye without the use of a mydriatic agent and is intended for use as an aid to clinicians in the evaluation, diagnosis and documentation of ocular health. iCam provides images only and does not provide any diagnostic, pathological analysis or classification of ocular health or disease. AND iVue with Normative Database (K121739) - The iVue is a noncontact, high resolution optical coherence tomography system intended for in vivo imaging, axial cross-sectional, three-dimensional imaging and measurement of anterior and posterior. ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue with Normative Database is a quantitative tool for comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616199. Last updated year: 2026. Please use registration number 9616199 when referencing this establishment in official correspondence.
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