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Medical DevicesKOSDAQ 14998069 approvals

Hironic Co.,Ltd

Official website

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

As of 2026-10-10, Hironic Co.,Ltd has 61 Korean MFDS device approvals, 8 US FDA clearances/approvals 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 2007 and listed on KOSDAQ in 2014, Hironic is an aesthetic dermatology medical device company. It manufactures and sells HIFU devices DOUBLO and V-RO, the non-invasive drug delivery system Synerjet, the picosecond laser PICOHI 300, the fat-reduction laser SLIMUS, the RF device GENTLO, and the plasma device PLASONIC. V-RO received manufacturing approval as V-RO 2.0 with added microneedle RF functionality in August 2023, PICOHI 300 and SLIMUS hold US FDA clearance, Synerjet holds European CE MDR certification, and personal home-care devices are sold through subsidiary Homethera Co., Ltd.

Products & technology

  • DOUBLOHIFU (high intensity focused ultrasound) skin lifting device
  • V-RO / V-RO 2.0combined HIFU+RF lifting device (SD handpiece; V-RO 2.0 adds microneedle RF)
  • Synerjetnon-invasive drug delivery system (micro-jetting, electroporation, plasma) for lifting, tightening, scar treatment, pigmentation, and hydration
  • PICOHI 300picosecond laser for pigmentation treatment and tattoo removal
  • SLIMUS1060nm diode laser non-invasive fat reduction device
  • GENTLOradiofrequency (RF) aesthetic device
  • PLASONICplasma aesthetic device
  • Hometherapersonal HIFU home-care beauty device (subsidiary Homethera Co., Ltd.)

Regulatory approvals

data.go.kr · openFDA

61 Korean MFDS device approvals · 2008–2026 / 8 US FDA 510(k) · 2018–2026

  • MFDSDiathermy treatment system, microwave2026-07-08
    Product approval · Class 2제인 26-4619 호
  • MFDSPlasma eletrosurgical unit2026-07-03
    Product approval · Class 3제허 26-512 호
  • MFDSInjector, medication/vaccine, needleless, gas-powered2026-04-21
    Product approval · Class 2제인 26-4350 호
  • FDASYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)2026-04-06
    510(k) · TraditionalGeneral, Plastic SurgeryK260397
  • MFDSElectrosurgical system, general-purpose2026-01-26
    Product approval · Class 3제허 26-72 호
  • FDANEW DOUBLO 2.02025-09-29
    510(k) · TraditionalGeneral, Plastic SurgeryK251334
  • MFDSDiathermy treatment system, microwave2025-04-15
    Product approval · Class 2제인 25-4311 호
  • FDAPlasonic (Plasonic)2024-11-08
    510(k) · TraditionalGeneral, Plastic SurgeryK241099
  • FDASILKRO2024-06-24
    510(k) · TraditionalGeneral, Plastic SurgeryK233123
  • MFDSElectrosurgical system, general-purpose2024-06-05
    Product approval · Class 3제허 24-386 호
  • MFDSFocused ultrasound stimulator system2023-08-29
    Product approval · Class 3제허 23-873 호
  • MFDSFocused ultrasound stimulator system2022-08-31
    Product approval · Class 3제허 22-587 호
Show 57 more
  • FDASILKRO2022-06-03
    510(k) · TraditionalGeneral, Plastic SurgeryK210084
  • FDAPICOHI2021-10-19
    510(k) · TraditionalGeneral, Plastic SurgeryK201773
  • MFDSFocused ultrasound stimulator system2021-08-13
    Product approval · Class 3제허 21-690 호
  • MFDSCooling2021-07-26
    Product approval · Class 2제인 21-4635 호
  • MFDSElectrosurgical system, general-purpose2021-05-17
    Product approval · Class 3제허 21-386 호
  • MFDSFocused ultrasound stimulator system2021-02-23
    Product approval · Class 3제허 21-142 호
  • MFDSFocused ultrasound stimulator system2020-12-18
    Product approval · Class 3제허 20-1110 호
  • MFDSElectrosurgical system electrode, foot-controlled, single-use2020-12-04
    Product approval · Class 2제인 20-5064 호
  • FDASLIMUS2020-12-01
    510(k) · TraditionalGeneral, Plastic SurgeryK192970
  • MFDSFocused ultrasound stimulator system2020-06-04
    Product approval · Class 3제허 20-444 호
  • MFDSLaser, surgical, Nd:YAG2020-01-28
    Product approval · Class 3제허 20-54 호
  • MFDSElectrosurgical system electrode, foot-controlled, single-use2019-03-04
    Product approval · Class 2제인 19-4143 호
  • MFDSElectrosurgical system, general-purpose2019-02-26
    Product approval · Class 3제허 19-122 호
  • MFDSLaser, surgical, Nd:YAG2019-02-26
    Product approval · Class 3제허 19-120 호
  • MFDSLaser, therapeuticRevoked2018-09-28
    Product approval · Class 3제허 18-654 호
  • FDAA-FIT2018-09-14
    510(k) · TraditionalGeneral, Plastic SurgeryK173676
  • MFDSVisible light irradiator for medical use, home use2018-08-07
    Product approval · Class 3제허 18-564 호
  • MFDSLaser, therapeutic2018-04-18
    Product approval · Class 3제허 18-272 호
  • MFDSFocused ultrasound stimulator system2018-03-23
    Product approval · Class 3제허 18-195 호
  • MFDSPhysical devices for medical use2018-03-12
    Product approval · Class 3제허 18-163 호
  • MFDSLaser, surgical, Nd:YAG2017-12-11
    Product approval · Class 3제허 17-926 호
  • MFDSLaser, therapeutic2017-09-04
    Product approval · Class 3제허 17-673 호
  • MFDSLaser surgical unit, diodeRevoked2017-06-01
    Product approval · Class 3제허 17-372 호
  • MFDSElectrosurgical system electrode, foot-controlled, single-useRevoked2017-05-17
    Product approval · Class 2제인 17-4354 호
  • MFDSLaser, surgical, Nd:YAG2017-02-23
    Product approval · Class 3제허 17-140 호
  • MFDSGraft/prosthesis, biomaterialRevoked2017-02-17
    Product approval · Class 4제허 17-124 호
  • MFDSGraft/prosthesis, biomaterialRevoked2017-02-17
    Product approval · Class 4제허 17-123 호
  • MFDSVisible light irradiator for medical use, home use2016-12-05
    Product approval · Class 3제허 16-923 호
  • MFDSInfusion pump, electrically-poweredRevoked2016-10-04
    Product approval · Class 2제인 16-4773 호
  • MFDSLaser surgical unit, diode2016-08-19
    Product approval · Class 3제허 16-622 호
  • MFDSLaser, therapeuticRevoked2016-06-29
    Product approval · Class 3제허 16-454 호
  • MFDSDiathermy treatment system operator console, high frequencyRevoked2016-02-16
    Product approval · Class 3제허 16-115 호
  • MFDSHair implant systemRevoked2015-09-18
    Product approval · Class 2제인 15-4146 호
  • MFDSHigh intensity focused Ultrasonic surgical system2015-05-18
    Product approval · Class 3제허 15-753 호
  • MFDSHair implant systemRevoked2015-03-23
    Product approval · Class 2제인 15-403 호
  • MFDSHigh intensity focused Ultrasonic surgical system2015-03-18
    Product approval · Class 3제허 15-382 호
  • MFDSSkin surface treatment system generator, multi-modalityRevoked2014-10-23
    Product approval · Class 3제허 14-1882 호
  • MFDSSkin surface treatment system generator, multi-modalityRevoked2014-10-01
    Product approval · Class 3제허 14-1767 호
  • MFDSCooling2014-08-22
    Product approval · Class 2제인 14-1523 호
  • MFDSCooling2014-08-04
    Product approval · Class 2제인 14-1433 호
  • MFDSHigh intensity focused Ultrasonic surgical system2014-03-14
    Product approval · Class 3제허 14-639 호
  • MFDSCooling2014-03-13
    Product approval · Class 2제인 14-621 호
  • MFDSCoolingRevoked2013-08-20
    Product approval · Class 2제인 13-1454 호
  • MFDSCoolingRevoked2013-04-30
    Product approval · Class 2제허 13-776 호
  • MFDSHigh intensity focused Ultrasonic surgical system2013-01-29
    Product approval · Class 3제허 13-291 호
  • MFDSLaser surgical unit, diodeRevoked2012-12-05
    Product approval · Class 3제허 12-1570 호
  • MFDSCombination stimulator, class 2Revoked2012-12-04
    Product approval · Class 2제인 12-1557 호
  • MFDSCoolingRevoked2012-02-15
    Product approval · Class 2제허 12-191 호
  • MFDSFocused ultrasound stimulator system2011-08-29
    Product approval · Class 3제허 11-946 호
  • MFDSSkin surface treatment system generator, multi-modalityRevoked2011-05-19
    Product approval · Class 3제허 11-547 호
  • MFDSHigh intensity focused Ultrasonic surgical system2011-03-08
    Product approval · Class 3제허 11-238 호
  • MFDSLaser surgical unit, diodeRevoked2010-06-04
    Product approval · Class 3제허 10-556 호
  • MFDSSkin surface treatment system generator, multi-modalityRevoked2010-03-16
    Product approval · Class 3제허 10-204 호
  • MFDSLaser, surgical, carbon dioxideRevoked2010-03-09
    Product approval · Class 3제허 10-185 호
  • MFDSSkin surface treatment system generator, multi-modalityRevoked2009-12-31
    Product approval · Class 3제허 09-1096 호
  • MFDSLaser, surgical, carbon dioxideRevoked2009-12-30
    Product approval · Class 3제허 09-1094 호
  • MFDSLight, lowpoweredRevoked2008-11-03
    Product approval · Class 2제허 08-791 호

R&D and key agreements

Source: DART corporate disclosure

광영상 가이드 다중색소병변치료용 레이저광의료기기 사업화개발 · 다중색소병변 치료 · 완료 · Government-led project (MOTIE) with Yonsei University, Seoul National University Hospital, GIST, and KITECH consortium; Oct 2015-Mar 2018 (30 months); government funding KRW 1,551 million

SU(비임상) Slimus 피하지방감소 유효성·안전성 평가 · 피하지방 감소 · 비임상 완료 · Non-clinical study, Oct 2017-Feb 2018 (5 months); government funding KRW 35.7 million

UV(비임상) HIFU 질이완증 치료기 유효성·안전성 전임상평가 · 질 이완증(vaginal tightening) · 전임상 · Preclinical animal study, Sep 2017-Jun 2018 (10 months); government funding KRW 40 million

532/755/1064/1450/2940nm 레이저 및 LED/UV 복합 광정발생장치 개발 · 제모·여드름·주름·문신제거·박피 등 피부질환 · 완료 · Apr 2017-Dec 2021 (57 months); government funding KRW 2,350 million

1060nm 레이저 비침습적 지방분해용 레이저광의료기기 개발 · 비침습 지방분해 · 완료 · Supported by KTL, Nov 2017-Oct 2018; government funding KRW 70 million

Key disclosures

KRX KIND via OpenDART
Show 5 more events

Patents

KIPRIS · applicant-matched
Show 216 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.16 shared

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

BTB Korea Co.,Ltd12 shared

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

WON TECH CO.,Ltd.12 shared

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

ASTERASYS Co., Ltd.4 shared

Founded in 2015 and listed on KOSDAQ in 2025, ASTERASYS manufactures HIFU and RF-based aesthetic skin devices.

LivsMed Inc.4 shared

KOSDAQ-listed minimally invasive surgical device company developing the ArtiSential multi-jointed laparoscopic instrument and ArtiSeal vessel sealer.

JETEMA Co.,Ltd.4 shared

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

Dynamic solution Co.,Ltd.4 shared

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

WonIk Co.,LTD3 shared

WonIk, founded in 1983 and KOSDAQ-listed in 1997, operates pressure sensor, dermo-cosmetic, and medical device distribution businesses.

REMED CO.,LTD.3 shared

KOSDAQ-listed magnetic stimulation medical device company developing TMS-based brain rehabilitation devices and PMS pain management devices.

DongBang Medical Co., Ltd.3 shared

KOSDAQ-listed medical device maker producing disposable acupuncture needles, cupping cups, and hyaluronic acid dermal fillers.

MEDIANA Co.,LTD3 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.

MITECH CO.,LTD.3 shared

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

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

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