CLASSYS Inc.
CLASSYS Inc., established in 2015 and listed on KOSDAQ, makes aesthetic medical devices using HIFU, MRF, MNRF, and laser technologies.
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Business overview
Source: DART corporate disclosureCLASSYS Inc. was established on January 15, 2015 and listed on KOSDAQ on April 3, 2015 as an aesthetic medical device company. Its product portfolio covers major EBD categories through the HIFU Ultraformer series, MRF Volnewmer (Everesse), MNRF Quadessy, and the reepot laser device. The company sells equipment together with consumables, serves distributors in more than 80 countries worldwide along with domestic and international clinics and individual consumers, merged with Iruda on October 1, 2024, and completed the acquisition of a stake in Brazil's JL Health Participacoes S.A. through its wholly owned subsidiary Classys Brasil Ltda. on March 5, 2026.
Products & technology
- ULTRAFORMER MPTFocused ultrasound (HIFU) aesthetic medical device
- UlfitFocused ultrasound (HIFU) aesthetic medical device
- VOLNEWMER / EveresseMonopolar RF (MRF) aesthetic medical device
- QUADESSYMicroneedle RF (MNRF) aesthetic medical device
- reepotLaser aesthetic medical device
- Elelay / curas hybridLaser aesthetic medical device
- VeloceIntense pulsed light (IPL) aesthetic medical device
- AQUAPURE I, IIOther aesthetic medical device
- RefitOther aesthetic medical device
- CLATUU AlphaOther aesthetic medical device
- Shurink Home LIFT2GLOWCosmetics and personal beauty device
- VOLIUMCosmetics and personal beauty device
- 리프팅 밴드Cosmetics and personal beauty device
Regulatory approvals
data.go.kr · openFDA121 Korean MFDS device approvals · 2003–2026 / 4 US FDA 510(k) · 2023–2026
- FDAVolnewmer2026-07-13
- MFDSLaser, surgical, Nd:YAG2026-06-22Product approval · Class 3제허 26-470 호
- MFDSSkin surface treatment system generator, multi-modality2026-06-19Product approval · Class 3제허 26-465 호
- MFDSFocused ultrasound stimulator system2026-03-18Product approval · Class 3제허 26-208 호
- MFDSDiathermy treatment system operator console, high frequency2026-01-14Product approval · Class 3제허 26-44 호
- FDACuRAS hybrid2025-11-20
- MFDSElectrosurgical system electrode, foot-controlled, single-use2024-06-24Product approval · Class 2제인 24-622 호
- MFDSElectrosurgical system, general-purpose2024-05-17Product approval · Class 3제허 24-342 호
- MFDSOphthalmic image, analysis softwareRevoked2024-05-16Product approval · Class 2제인 24-484 호
- MFDSElectrode, external2024-05-03Product approval · Class 1수신 24-794 호
- FDAVolnewmer2024-04-29
- MFDSGel for medical use, non-sterilized2024-04-22Product approval · Class 1제신 24-494 호
Show 68 more
- MFDSLaser surgical unit, diode2024-03-13Product approval · Class 3제허 24-189 호
- MFDSFundus cameraRevoked2024-02-21Product approval · Class 2제인 24-187 호
- FDASCIZER (SC1-M410)2023-11-03
- MFDSGel for medical use, non-sterilized2023-09-07Product approval · Class 1제신 23-1352 호
- MFDSRadiation shield, spectacles2023-05-26Product approval · Class 1수신 23-1337 호
- MFDSRadiation shield, spectacles2023-02-24Product approval · Class 1수신 23-327 호
- MFDSElectrode, external2023-02-24Product approval · Class 1제신 23-222 호
- MFDSElectrosurgical system electrode, foot-controlled, single-use2022-09-13Product approval · Class 2제인 22-4656 호
- MFDSElectrode, external2022-08-04Product approval · Class 1제신 22-1090 호
- MFDSElectrosurgical system, general-purpose2022-08-01Product approval · Class 3제허 22-512 호
- MFDSGel for medical use, non-sterilized2022-06-16Product approval · Class 1제신 22-815 호
- MFDSGuide for medical use2022-05-06Product approval · Class 1제신 22-622 호
- MFDSGel for medical use, non-sterilized2022-05-02Product approval · Class 1제신 22-593 호
- MFDSGuide for medical use2022-04-29Product approval · Class 1제신 22-587 호
- MFDSLaser, surgical, Nd:YAG2022-04-15Product approval · Class 3제허 22-251 호
- MFDSRadiation shield, spectacles2022-03-17Product approval · Class 1수신 22-455 호
- MFDSLaser surgical unit, diode2022-03-11Product approval · Class 3제허 22-160 호
- MFDSLaser, surgical, Nd:YAG2022-03-07Product approval · Class 3제허 22-148 호
- MFDSElectrosurgical system electrode, hand-controlled, general-purpose, single-use2022-01-27Product approval · Class 2제인 22-4061 호
- MFDSFocused ultrasound stimulator system2021-10-06Product approval · Class 3제허 21-831 호
- MFDSPhototherapy unit, infraredRevoked2021-10-01Product approval · Class 2제인 21-4842 호
- MFDSThermometer, electronic, infrared, skinRevoked2021-09-02Product approval · Class 2제인 21-4765 호
- MFDSElectrosurgical system electrode, foot-controlled, reusableRevoked2021-09-01Product approval · Class 2제인 21-4760 호
- MFDSSuction system, general-purpose, line-powered2021-08-19Product approval · Class 2제인 21-4720 호
- MFDSSkin surface treatment system generator, multi-modalityRevoked2021-08-10Product approval · Class 3제허 21-676 호
- MFDSGel for medical use, non-sterilizedRevoked2021-06-11Product approval · Class 1제신 21-854 호
- MFDSPhototherapy unit, infraredRevoked2021-05-06Product approval · Class 2제인 21-4387 호
- MFDSFundus cameraRevoked2021-04-13Product approval · Class 2제인 21-4293 호
- MFDSElectrosurgical system, general-purpose2021-02-22Product approval · Class 3제허 21-133 호
- MFDSGel for medical use, non-sterilizedRevoked2020-11-17Product approval · Class 1제신 20-1668 호
- MFDSFocused ultrasound stimulator systemRevoked2020-05-18Product approval · Class 3제허 20-372 호
- MFDSLaser, surgical, Nd:YAGRevoked2020-01-31Product approval · Class 3제허 20-66 호
- MFDSLaser surgical unit, diodeRevoked2020-01-28Product approval · Class 3제허 20-53 호
- MFDSElectrosurgical system electrode, foot-controlled, single-use2020-01-16Product approval · Class 2제인 20-4033 호
- MFDSLaser surgical unit, diodeRevoked2019-12-03Product approval · Class 3제허 19-789 호
- MFDSElectrode, external2019-11-15Product approval · Class 1제신 19-1491 호
- MFDSLaser surgical unit, diode2019-11-07Product approval · Class 3제허 19-708 호
- MFDSRadiation shield, spectacles2019-10-02Product approval · Class 1수신 19-2504 호
- MFDSTrephine system, electrically-poweredRevoked2019-05-15Product approval · Class 2제인 19-4393 호
- MFDSFocused ultrasound stimulator system2019-04-03Product approval · Class 3제허 19-201 호
- MFDSFocused ultrasound stimulator systemRevoked2019-03-28Product approval · Class 3제허 19-192 호
- MFDSSuction system, general-purpose, line-powered2019-03-08Product approval · Class 2제인 19-4170 호
- MFDSRadiation shield, spectacles2019-03-08Product approval · Class 1수신 19-541 호
- MFDSCooling2019-01-29Product approval · Class 2제인 19-4072 호
- MFDSCooling2019-01-03Product approval · Class 2제인 19-4003 호
- MFDSAbrasive device2018-12-21Product approval · Class 1제신 18-1711 호
- MFDSLaser surgical unit, diodeRevoked2018-05-18Product approval · Class 3제허 18-368 호
- MFDSElectrosurgical system, general-purpose2018-03-22Product approval · Class 3제허 18-190 호
- MFDSInfusion pump, electrically-poweredRevoked2018-03-06Product approval · Class 2제인 18-4166 호
- MFDSAbrasive device2018-02-20Product approval · Class 1제신 18-217 호
- MFDSLaser surgical unit, diodeRevoked2018-02-13Product approval · Class 3제허 18-90 호
- MFDSTrephine system, electrically-poweredRevoked2018-02-13Product approval · Class 2제인 18-4112 호
- MFDSSuction system, general-purpose, line-powered2018-01-19Product approval · Class 2제인 18-4046 호
- MFDSSystem, medical image processing device2017-12-18Product approval · Class 1제신 17-1420 호
- MFDSLight, examination, mobile2017-12-14Product approval · Class 1제신 17-1412 호
- MFDSLaser surgical unit, diodeRevoked2017-11-21Product approval · Class 3제허 17-884 호
- MFDSMicroscope, light, ophthalmic, slit2017-11-16Product approval · Class 1제신 17-1314 호
- MFDSElectrosurgical system electrode, foot-controlled, single-use2017-09-11Product approval · Class 2제인 17-4716 호
- MFDSLaser surgical unit, diodeRevoked2017-09-01Product approval · Class 3제허 17-671 호
- MFDSDirect infusion deviceRevoked2017-06-26Product approval · Class 2제인 17-4506 호
- MFDSElectrosurgical system electrode, foot-controlled, single-use2017-05-02Product approval · Class 2제인 17-4314 호
- MFDSFocused ultrasound stimulator system2017-04-10Product approval · Class 3제허 17-256 호
- MFDSInfusion pump, electrically-poweredRevoked2017-04-04Product approval · Class 2제인 17-4251 호
- MFDSDiathermy treatment system operator console, high frequency2017-03-09Product approval · Class 3제허 17-173 호
- MFDSLaser, therapeuticRevoked2017-01-25Product approval · Class 3제허 17-78 호
- MFDSLaser surgical unit, diodeRevoked2017-01-13Product approval · Class 3제허 17-39 호
- MFDSFundus cameraRevoked2016-08-12Product approval · Class 2제인 16-4669 호
- MFDSLaser surgical unit, diodeRevoked2016-08-11Product approval · Class 3제허 16-598 호
Showing the 80 most recent of 125 records.
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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.
Founded in 2019 and KOSDAQ-listed the same year, WON TECH makes aesthetic laser, RF, and HIFU devices including Oligio and Picocare.
KOSDAQ-listed medical device company producing HIFU devices DOUBLO/V-RO and the Synerjet non-invasive drug delivery system for aesthetic dermatology.
KOSDAQ-listed aesthetic medical device company producing PICO, DUAL HI, and other anti-aging and body-contouring devices.
KOSDAQ-listed magnetic stimulation medical device company developing TMS-based brain rehabilitation devices and PMS pain management devices.
Founded in 2010 and KOSDAQ-listed in 2018, Sejong Medical manufactures laparoscopic surgical instruments.
Founded in 1964 and KOSPI-listed in 1991, Shinhung manufactures and distributes dental equipment and materials.
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.
WonIk, founded in 1983 and KOSDAQ-listed in 1997, operates pressure sensor, dermo-cosmetic, and medical device distribution businesses.
Founded in 2010 and KOSDAQ-listed in 2018, Dynamic Solution makes AI/IoT-based rehabilitation devices like the Rapael Smart Glove.
Alpha AI, founded in 1995 and KOSDAQ-listed in 2000, manufactures biocompatible metal implants and surgical instruments.
KOSDAQ-listed minimally invasive surgical device company developing the ArtiSential multi-jointed laparoscopic instrument and ArtiSeal vessel sealer.
Sources and updates
- Company basics
- Korea Exchange · DART
- Business content
- Compiled from disclosure filings
- AI visibility
- Measured 2026-08-13
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