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Medical DevicesKOSDAQ 06551066 approvals

Huvitz Co., Ltd.

Official website

KOSDAQ-listed medical device company producing auto refractors, auto lensmeters, and other ophthalmic equipment.

As of 2026-10-11, Huvitz Co., Ltd. has 62 Korean MFDS device approvals, 4 US FDA clearances/approvals, 6 PubMed-indexed papers on record (counted by the MAA Company Index from its own matching of public databases).

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Market cap

Business overview

Source: DART corporate disclosure

Founded in 1999 and listed on KOSDAQ in 2003, Huvitz is an ophthalmic and optical medical device company. It manufactures auto refractors and auto lensmeters as core products, along with the SmartBlocker HBK-410, fundus camera SOLO (HFC-1), lens edger HPE-910, and OCT devices HOCT-1 and HOCT-1F. The integrated-drill edger HPE-910 improved processing time by an average of 30%, and its OCTA (Angio) research project (Dec 2017-Dec 2019) developed layer-based angiography mapping and FAZ/vessel density detection features.

Products & technology

  • auto refractorautomated eye examination for opticians and ophthalmology
  • auto lensmeterautomated lens power measurement
  • SmartBlocker (HBK-410)lens processing blocking device
  • Fundus camera SOLO (HFC-1)fundus camera
  • High-End-Edger (HPE-910)integrated-drill lens edger
  • HOCT-1/HOCT-1FOCT (optical coherence tomography) device

Regulatory approvals

data.go.kr · openFDA

62 Korean MFDS device approvals · 1999–2026 / 4 US FDA 510(k) · 2017–2023

  • MFDSKeratometer2026-02-12
    Product approval · Class 2제인 26-4143 호
  • MFDSVisual acuity projector2025-11-17
    Product approval · Class 1제신 25-1509 호
  • MFDSStomatoscope, flexible, fibreoptic2024-11-07
    Product approval · Class 2제인 24-999 호
  • MFDSOphthalmic refractometer2024-06-21
    Product approval · Class 2제인 24-608 호
  • MFDSOphthalmic examination/treatment table/stand, electrically- powered2024-01-24
    Product approval · Class 2제인 24-98 호
  • MFDSTable and chair, examination/treatment, ophthalmic2023-11-23
    Product approval · Class 2제인 23-5289 호
  • FDAApplanation Tonometer HT-50002023-10-23
    510(k) · TraditionalOphthalmicK232143
  • MFDSStomatoscope, flexible, fibreoptic2023-10-18
    Product approval · Class 2제인 23-5175 호
  • MFDSTable and chair, examination/treatment, ophthalmic2023-07-07
    Product approval · Class 2제인 23-4883 호
  • MFDSOphthalmic examination/treatment table/stand, electrically- powered2023-07-05
    Product approval · Class 2제인 23-4876 호
  • MFDSVisual acuity projector2022-09-19
    Product approval · Class 1수신 22-1595 호
  • MFDSFundus camera2022-08-23
    Product approval · Class 2제인 22-4616 호
Show 54 more
  • MFDSPerimeter, automatic2022-06-02
    Product approval · Class 1수신 22-975 호
  • MFDSOphthalmic refractometer2022-01-25
    Product approval · Class 2제인 22-4052 호
  • MFDSOphthalmic refractometerRevoked2021-10-15
    Product approval · Class 2수인 21-4490 호
  • MFDSOphthalmic image, analysis software2021-07-14
    Product approval · Class 2제인 21-4603 호
  • MFDSProduct name not recorded2021-07-14
    Product approval · Class 2인 21-4603 호
  • MFDSKeratometer2021-03-04
    Product approval · Class 2제인 21-4162 호
  • MFDSKeratometer2021-03-04
    Product approval · Class 2제인 21-4161 호
  • MFDSVisual acuity projector2021-02-25
    Product approval · Class 1제신 21-248 호
  • FDAFundus Camera2021-02-02
    510(k) · TraditionalOphthalmicK202097
  • MFDSCamera, ophthalmic2020-10-13
    Product approval · Class 1수신 20-2383 호
  • MFDSOphthalmic refractometer2020-05-14
    Product approval · Class 2제인 20-4375 호
  • MFDSFundus camera2019-11-19
    Product approval · Class 2제인 19-4950 호
  • MFDSTrial lens frame2019-08-22
    Product approval · Class 1수신 19-2106 호
  • FDAHuvitz Imaging System2019-07-18
    510(k) · SpecialRadiologyK191615
  • MFDSOphthalmodiastimeter2019-05-28
    Product approval · Class 1수신 19-1279 호
  • MFDSVisual acuity projector2018-05-17
    Product approval · Class 1수신 18-1011 호
  • MFDSFundus camera2018-01-02
    Product approval · Class 2제인 18-4001 호
  • MFDSOphthalmic refractometer2017-09-19
    Product approval · Class 2제인 17-4745 호
  • MFDSOphthalmic refractometer2017-07-04
    Product approval · Class 2제인 17-4534 호
  • MFDSOphthalmic examination/treatment table/stand, electrically- powered2017-06-01
    Product approval · Class 2제인 17-4431 호
  • FDAHuvitz Imaging System2017-04-06
    510(k) · TraditionalRadiologyK161829
  • MFDSTonometer, battery-operated2017-03-08
    Product approval · Class 2제인 17-4167 호
  • MFDSOphthalmic refractometer2015-05-26
    Product approval · Class 2제인 15-796 호
  • MFDSOphthalmic refractometer2015-04-14
    Product approval · Class 2제인 15-546 호
  • MFDSVisual acuity chart2015-03-10
    Product approval · Class 1경인 제신 15-97 호
  • MFDSVisual acuity chartRevoked2015-02-11
    Product approval · Class 1경인 수신 15-67 호
  • MFDSCamera, ophthalmic2015-01-12
    Product approval · Class 1경인 제신 15-27 호
  • MFDSTable and chair, examination/treatment, ophthalmic2013-11-22
    Product approval · Class 2제인 13-1983 호
  • MFDSTable and chair, examination/treatment, ophthalmicRevoked2013-11-22
    Product approval · Class 2수인 13-2839 호
  • MFDSTrial lens2013-08-26
    Product approval · Class 1경인 수신 13-347 호
  • MFDSFundus cameraRevoked2013-08-14
    Product approval · Class 2수허 13-1478 호
  • MFDSMicroscope, light, ophthalmic2013-05-14
    Product approval · Class 1경인 제신 13-225 호
  • MFDSTrial lens2013-04-03
    Product approval · Class 1경인 수신 13-151 호
  • MFDSOphthalmic refractometerRevoked2013-03-14
    Product approval · Class 2수인 13-499 호
  • MFDSVisual acuity projector2011-12-20
    Product approval · Class 1경인 제신 11-359 호
  • MFDSTonometer, battery-operated2011-03-28
    Product approval · Class 2제인 11-1331 호
  • MFDSOphthalmic refractometer2011-03-16
    Product approval · Class 2제인 11-287 호
  • MFDSTonometer, battery-operated2010-04-15
    Product approval · Class 2제인 10-352 호
  • MFDSMicroscope, light, ophthalmic, slit2009-08-14
    Product approval · Class 1경인 제신 09-251 호
  • MFDSVisual acuity chart2008-10-01
    Product approval · Class 1경인 제신 08-264 호
  • MFDSOphthalmic refractometer2008-08-08
    Product approval · Class 2제인 08-517 호
  • MFDSOphthalmic refractometer2008-06-10
    Product approval · Class 2제인 08-355 호
  • MFDS의료용영상처리용장치·소프트웨어Revoked2008-05-21
    Product approval · Class 1경인 제신 08-141 호
  • MFDS의료용영상처리용장치·소프트웨어Revoked2007-10-16
    Product approval · Class 1경인 제신 07-263 호
  • MFDSOphthalmic refractometerRevoked2007-06-25
    Product approval · Class 2제인 07-339 호
  • MFDS틈새등현미경Revoked2006-07-12
    Product approval · Class 2제허 06-494 호
  • MFDS진료용의자Revoked2004-04-13
    Product approval · Class 1경인 제신 04-32 호
  • MFDSVisual acuity chartRevoked2003-07-30
    Product approval · Class 1경인 제신 03-87 호
  • MFDSOphthalmic refractometerRevoked2002-08-29
    Product approval · Class 2제허 02-703 호
  • MFDS진료용의자Revoked2002-08-08
    Product approval · Class 1경인 제신 02-79 호
  • MFDSVisual acuity chart2002-07-12
    Product approval · Class 1경인 제신 02-71 호
  • MFDS시력표Revoked2001-02-23
    Product approval · Class 1경인 제신 01-6 호
  • MFDSOphthalmic refractometerRevoked2000-10-24
    Product approval · Class 2제허 00-435 호
  • MFDS검안용굴절력측정기Revoked1999-11-23
    Product approval · Class 2제허 99-347 호

R&D and key agreements

Source: DART corporate disclosure

OCTA(Angio) 개발 · 망막 혈관조영 진단 · 완료(2017.12-2019.12) · Developed layer-based angiography mapping (superficial, deep, outer, choriocapillary), FAZ detection, and vessel density detection

New SmartBlocker 개발(HBK-410) · 안경렌즈 가공 · 완료(2018.01-2019.02) · CAM-driven single-push blocking arm achieving blocking tolerance of ±0.5mm/±1 degree

드릴일체형 High-End-Edger 개발(HPE-910) · 안경렌즈 가공 · 완료(2019.01-2020.02) · Reduced processing time by an average of 30%; supports 16 model options across XD/X/D/N types

Key disclosures

KRX KIND via OpenDART

Publications

PubMed · affiliation-matched

Patents

KIPRIS · applicant-matched
Show 402 more patents

AI reads

MAA server logs · IP-verified
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Companies approved for the same productsMedical Devices

Ranked by how many MFDS product categories overlap. Not a ranking — a pointer to where to look.

CLASSYS Inc.2 shared

CLASSYS Inc., established in 2015 and listed on KOSDAQ, makes aesthetic medical devices using HIFU, MRF, MNRF, and laser technologies.

DIO Corporation1 shared

DIO Corporation, established in 1988 and listed on KOSDAQ in 2000, manufactures and sells dental implants.

Dynamic solution Co.,Ltd.1 shared

Founded in 2010 and KOSDAQ-listed in 2018, Dynamic Solution makes AI/IoT-based rehabilitation devices like the Rapael Smart Glove.

JPI Healthcare Co., Ltd.1 shared

JPI Healthcare, founded 1980, makes X-ray imaging device components and equipment, listed on KOSDAQ in August 2025.

Kukje Pharma Co., Ltd.1 shared

Founded in 1959, Kukje Pharma produces prescription and OTC drugs including Cuallon eye drops, Cholencina capsules, and Retium tablets.

RAYENCE CO.,LTD.1 shared

KOSDAQ-listed X-ray imaging solution company with a full lineup of medical, dental, veterinary, and industrial X-ray detectors.

ROKIT HEALTHCARE Inc.1 shared

KOSDAQ-listed medical device company with an organ regeneration platform expanding from diabetic foot skin regeneration into cartilage and kidney regeneration.

SHINHUNG CO.,LTD1 shared

Founded in 1964 and KOSPI-listed in 1991, Shinhung manufactures and distributes dental equipment and materials.

INTEROJO CO. LTD.100

Interojo, founded 2000 and KOSDAQ-listed 2010, manufactures contact lenses under its Clalen brand domestically and via OEM/ODM overseas.

MITECH CO.,LTD.100

MITECH CO.,LTD., founded in 1991 and listed on KOSDAQ in 2018, makes non-vascular stents and distributes Fujifilm endoscopy equipment.

JETEMA Co.,Ltd.90

Founded 2009, listed on KOSDAQ in 2019, JETEMA develops hyaluronic acid fillers, botulinum toxin biopharmaceuticals, and lifting threads.

Corentec Co., Ltd.85

Founded in 2000 and KOSDAQ-listed in 2013, Corentec makes artificial joints; hip and knee implants exceed 85% of revenue.

Sources and updates

Counts on this page are not company-reported figures. MAA matched records from DART, the Korean MFDS, the US FDA, ClinicalTrials.gov, PubMed and KIPRIS to this company itself, by business registration number or registered name, never by name similarity. They may differ from figures the company publishes.

Company basics
Korea Exchange · DART
Business content
Compiled from disclosure filings
Approvals & clinical trials
Korean MFDS (data.go.kr) · US FDA openFDA — updated weekly
Key disclosures
KRX KIND via OpenDART exchange filings — updated daily
Global clinical trials
ClinicalTrials.gov (US NIH) — sponsor-matched, updated weekly
Financials
DART corporate disclosure filings — annual
Publications
PubMed (US National Library of Medicine) — affiliation-matched, updated daily
Patents
KIPRIS (Korea Institute of Patent Information) — applicant-matched, updated monthly
AI reads
Our server logs, IP-verified every 6 hours
AI visibility
Measured 2026-10-01

This page is compiled from public sources without the company's involvement. If anything is inaccurate or incomplete, please let us know. Materials provided by the company are labelled as such.

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