Hironic Co.,Ltd
KOSDAQ-listed medical device company producing HIFU devices DOUBLO/V-RO and the Synerjet non-invasive drug delivery system for aesthetic dermatology.
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Business overview
Source: DART corporate disclosureFounded 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 · openFDA61 Korean MFDS device approvals · 2008–2026 / 8 US FDA 510(k) · 2018–2026
- MFDSDiathermy treatment system, microwave2026-07-08Product approval · Class 2제인 26-4619 호
- MFDSPlasma eletrosurgical unit2026-07-03Product approval · Class 3제허 26-512 호
- MFDSInjector, medication/vaccine, needleless, gas-powered2026-04-21Product approval · Class 2제인 26-4350 호
- FDASYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)2026-04-06
- MFDSElectrosurgical system, general-purpose2026-01-26Product approval · Class 3제허 26-72 호
- FDANEW DOUBLO 2.02025-09-29
- MFDSDiathermy treatment system, microwave2025-04-15Product approval · Class 2제인 25-4311 호
- FDAPlasonic (Plasonic)2024-11-08
- FDASILKRO2024-06-24
- MFDSElectrosurgical system, general-purpose2024-06-05Product approval · Class 3제허 24-386 호
- MFDSFocused ultrasound stimulator system2023-08-29Product approval · Class 3제허 23-873 호
- MFDSFocused ultrasound stimulator system2022-08-31Product approval · Class 3제허 22-587 호
Show 57 more
- FDASILKRO2022-06-03
- FDAPICOHI2021-10-19
- MFDSFocused ultrasound stimulator system2021-08-13Product approval · Class 3제허 21-690 호
- MFDSCooling2021-07-26Product approval · Class 2제인 21-4635 호
- MFDSElectrosurgical system, general-purpose2021-05-17Product approval · Class 3제허 21-386 호
- MFDSFocused ultrasound stimulator system2021-02-23Product approval · Class 3제허 21-142 호
- MFDSFocused ultrasound stimulator system2020-12-18Product approval · Class 3제허 20-1110 호
- MFDSElectrosurgical system electrode, foot-controlled, single-use2020-12-04Product approval · Class 2제인 20-5064 호
- FDASLIMUS2020-12-01
- MFDSFocused ultrasound stimulator system2020-06-04Product approval · Class 3제허 20-444 호
- MFDSLaser, surgical, Nd:YAG2020-01-28Product approval · Class 3제허 20-54 호
- MFDSElectrosurgical system electrode, foot-controlled, single-use2019-03-04Product approval · Class 2제인 19-4143 호
- MFDSElectrosurgical system, general-purpose2019-02-26Product approval · Class 3제허 19-122 호
- MFDSLaser, surgical, Nd:YAG2019-02-26Product approval · Class 3제허 19-120 호
- MFDSLaser, therapeuticRevoked2018-09-28Product approval · Class 3제허 18-654 호
- FDAA-FIT2018-09-14
- MFDSVisible light irradiator for medical use, home use2018-08-07Product approval · Class 3제허 18-564 호
- MFDSLaser, therapeutic2018-04-18Product approval · Class 3제허 18-272 호
- MFDSFocused ultrasound stimulator system2018-03-23Product approval · Class 3제허 18-195 호
- MFDSPhysical devices for medical use2018-03-12Product approval · Class 3제허 18-163 호
- MFDSLaser, surgical, Nd:YAG2017-12-11Product approval · Class 3제허 17-926 호
- MFDSLaser, therapeutic2017-09-04Product approval · Class 3제허 17-673 호
- MFDSLaser surgical unit, diodeRevoked2017-06-01Product approval · Class 3제허 17-372 호
- MFDSElectrosurgical system electrode, foot-controlled, single-useRevoked2017-05-17Product approval · Class 2제인 17-4354 호
- MFDSLaser, surgical, Nd:YAG2017-02-23Product approval · Class 3제허 17-140 호
- MFDSGraft/prosthesis, biomaterialRevoked2017-02-17Product approval · Class 4제허 17-124 호
- MFDSGraft/prosthesis, biomaterialRevoked2017-02-17Product approval · Class 4제허 17-123 호
- MFDSVisible light irradiator for medical use, home use2016-12-05Product approval · Class 3제허 16-923 호
- MFDSInfusion pump, electrically-poweredRevoked2016-10-04Product approval · Class 2제인 16-4773 호
- MFDSLaser surgical unit, diode2016-08-19Product approval · Class 3제허 16-622 호
- MFDSLaser, therapeuticRevoked2016-06-29Product approval · Class 3제허 16-454 호
- MFDSDiathermy treatment system operator console, high frequencyRevoked2016-02-16Product approval · Class 3제허 16-115 호
- MFDSHair implant systemRevoked2015-09-18Product approval · Class 2제인 15-4146 호
- MFDSHigh intensity focused Ultrasonic surgical system2015-05-18Product approval · Class 3제허 15-753 호
- MFDSHair implant systemRevoked2015-03-23Product approval · Class 2제인 15-403 호
- MFDSHigh intensity focused Ultrasonic surgical system2015-03-18Product approval · Class 3제허 15-382 호
- MFDSSkin surface treatment system generator, multi-modalityRevoked2014-10-23Product approval · Class 3제허 14-1882 호
- MFDSSkin surface treatment system generator, multi-modalityRevoked2014-10-01Product approval · Class 3제허 14-1767 호
- MFDSCooling2014-08-22Product approval · Class 2제인 14-1523 호
- MFDSCooling2014-08-04Product approval · Class 2제인 14-1433 호
- MFDSHigh intensity focused Ultrasonic surgical system2014-03-14Product approval · Class 3제허 14-639 호
- MFDSCooling2014-03-13Product approval · Class 2제인 14-621 호
- MFDSCoolingRevoked2013-08-20Product approval · Class 2제인 13-1454 호
- MFDSCoolingRevoked2013-04-30Product approval · Class 2제허 13-776 호
- MFDSHigh intensity focused Ultrasonic surgical system2013-01-29Product approval · Class 3제허 13-291 호
- MFDSLaser surgical unit, diodeRevoked2012-12-05Product approval · Class 3제허 12-1570 호
- MFDSCombination stimulator, class 2Revoked2012-12-04Product approval · Class 2제인 12-1557 호
- MFDSCoolingRevoked2012-02-15Product approval · Class 2제허 12-191 호
- MFDSFocused ultrasound stimulator system2011-08-29Product approval · Class 3제허 11-946 호
- MFDSSkin surface treatment system generator, multi-modalityRevoked2011-05-19Product approval · Class 3제허 11-547 호
- MFDSHigh intensity focused Ultrasonic surgical system2011-03-08Product approval · Class 3제허 11-238 호
- MFDSLaser surgical unit, diodeRevoked2010-06-04Product approval · Class 3제허 10-556 호
- MFDSSkin surface treatment system generator, multi-modalityRevoked2010-03-16Product approval · Class 3제허 10-204 호
- MFDSLaser, surgical, carbon dioxideRevoked2010-03-09Product approval · Class 3제허 10-185 호
- MFDSSkin surface treatment system generator, multi-modalityRevoked2009-12-31Product approval · Class 3제허 09-1096 호
- MFDSLaser, surgical, carbon dioxideRevoked2009-12-30Product approval · Class 3제허 09-1094 호
- MFDSLight, lowpoweredRevoked2008-11-03Product approval · Class 2제허 08-791 호
R&D and key agreements
Source: DART corporate disclosure광영상 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
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., established in 2015 and listed on KOSDAQ, makes aesthetic medical devices using HIFU, MRF, MNRF, and laser technologies.
KOSDAQ-listed aesthetic medical device company producing PICO, DUAL HI, and other anti-aging and body-contouring devices.
Founded in 2019 and KOSDAQ-listed the same year, WON TECH makes aesthetic laser, RF, and HIFU devices including Oligio and Picocare.
Founded in 2010 and KOSDAQ-listed in 2018, Dynamic Solution makes AI/IoT-based rehabilitation devices like the Rapael Smart Glove.
Founded 2009, listed on KOSDAQ in 2019, JETEMA develops hyaluronic acid fillers, botulinum toxin biopharmaceuticals, and lifting threads.
KOSDAQ-listed minimally invasive surgical device company developing the ArtiSential multi-jointed laparoscopic instrument and ArtiSeal vessel sealer.
KOSDAQ-listed medical device maker producing disposable acupuncture needles, cupping cups, and hyaluronic acid dermal fillers.
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., founded in 1991 and listed on KOSDAQ in 2018, makes non-vascular stents and distributes Fujifilm endoscopy equipment.
KOSDAQ-listed magnetic stimulation medical device company developing TMS-based brain rehabilitation devices and PMS pain management devices.
WonIk, founded in 1983 and KOSDAQ-listed in 1997, operates pressure sensor, dermo-cosmetic, and medical device distribution businesses.
Sources and updates
- Company basics
- Korea Exchange · DART
- Business content
- Compiled from disclosure filings
- AI visibility
- Measured 2026-08-13
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