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Medical DevicesKOSDAQ 45095021 approvals

ASTERASYS Co., Ltd.

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Regulatory approvals

data.go.kr · openFDA

20 Korean MFDS device approvals · 2015–2025 / 1 US FDA 510(k) · 2025

  • FDACoolfase2025-10-16
    510(k) · TraditionalGeneral, Plastic SurgeryK250852
  • MFDSFocused ultrasound stimulator system2025-02-07
    Product approval · Class 3제허 25-78 호
  • MFDSTransducer assembly, ultrasound, therapeutic, diathermy2024-08-19
    Product approval · Class 2제인 24-786 호
  • MFDSElectrosurgical system, general-purpose2024-04-26
    Product approval · Class 3제허 24-294 호
  • MFDSElectrode, external2024-02-02
    Product approval · Class 1수신 24-190 호
  • MFDSGel for medical use, non-sterilized2023-10-17
    Product approval · Class 1제신 23-1517 호
  • MFDSElectrosurgical system electrode, hand-controlled, general-purpose, single-use2023-10-10
    Product approval · Class 2제인 23-5144 호
  • MFDSElectrode, external2023-05-19
    Product approval · Class 1수신 23-1288 호
  • MFDSFocused ultrasound stimulator system2020-08-20
    Product approval · Class 3제허 20-684 호
  • MFDSFocused ultrasound stimulator system2020-06-18
    Product approval · Class 3제허 20-492 호
  • MFDSElectrosurgical system, general-purpose2020-05-28
    Product approval · Class 3제허 20-395 호
  • MFDSElectrosurgical system electrode, hand-controlled, general-purpose, single-use2020-03-13
    Product approval · Class 2제인 20-4201 호
Show 9 more
  • MFDSFocused ultrasound stimulator system2020-02-17
    Product approval · Class 3제허 20-123 호
  • MFDSFocused ultrasound stimulator system2019-04-15
    Product approval · Class 3제허 19-237 호
  • MFDSSuction system, general-purpose, line-powered2018-04-20
    Product approval · Class 2제인 18-4305 호
  • MFDSElectrosurgical system, general-purpose2018-04-20
    Product approval · Class 3제허 18-283 호
  • MFDSElectrosurgical system, general-purpose2018-04-20
    Product approval · Class 3제허 18-282 호
  • MFDSFocused ultrasound stimulator systemRevoked2017-07-21
    Product approval · Class 3제허 17-541 호
  • MFDSBody fat/lean ratio analyser, impedanceRevoked2016-09-21
    Product approval · Class 2제인 16-4753 호
  • MFDSFocused ultrasound stimulator system2016-06-14
    Product approval · Class 3제허 16-425 호
  • MFDSBody fat/lean ratio analyser, impedanceRevoked2015-09-15
    Product approval · Class 2제인 15-4148 호
Not yet compiled: business overview · products · R&D. Send us materials and we will add them

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.9 shared

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

WON TECH CO.,Ltd.7 shared

Founded in 2019 and KOSDAQ-listed the same year, WON TECH makes aesthetic laser, RF, and HIFU devices including Oligio and Picocare.

BIO PROTECH INC.4 shared

Manufactures biosensors for electronic medical device consumables, including ECG measurement electrodes.

BTB Korea Co.,Ltd4 shared

KOSDAQ-listed aesthetic medical device company producing PICO, DUAL HI, and other anti-aging and body-contouring devices.

Hironic Co.,Ltd4 shared

KOSDAQ-listed medical device company producing HIFU devices DOUBLO/V-RO and the Synerjet non-invasive drug delivery system for aesthetic dermatology.

CG MedTech Co.,Ltd.3 shared

Founded in 1997 and KOSDAQ-listed in 2015, CG MedTech makes orthopedic medical devices and also operates an electric energy business.

JPI Healthcare Co., Ltd.3 shared

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

SHINHUNG CO.,LTD3 shared

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

CU MEDICAL SYSTEMS Inc.3 shared

Founded in 2001 and KOSDAQ-listed in 2011, CU Medical Systems makes AEDs and other emergency medical devices.

SEJONG MEDICAL Co.Ltd.,2 shared

Founded in 2010 and KOSDAQ-listed in 2018, Sejong Medical manufactures laparoscopic surgical instruments.

MEDIANA Co.,LTD2 shared

Founded in 1995 and listed on KOSDAQ in 2014, Mediana is a hospital medical device maker developing and manufacturing patient monitors and automated external defibrillators under its own brand and via ODM.

OSTEONIC Co., Ltd.2 shared

Established in 2012 and listed on KOSDAQ in 2018, Osteonic manufactures implants for the CMF, Trauma, Sports Medicine, and Spine categories.

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Korea Exchange · DART
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Measured 2026-08-13

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