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Medical DevicesKOSDAQ 214150125 approvals

CLASSYS Inc.

Official website

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

As of 2026-10-10, CLASSYS Inc. has 121 Korean MFDS device approvals, 4 US FDA clearances/approvals, 10 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

CLASSYS 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 · openFDA

121 Korean MFDS device approvals · 2003–2026 / 4 US FDA 510(k) · 2023–2026

  • FDAVolnewmer™2026-07-13
    510(k) · TraditionalGeneral, Plastic SurgeryK253504
  • MFDSLaser, surgical, Nd:YAG2026-06-22
    Product approval · Class 3제허 26-470 호
  • MFDSSkin surface treatment system generator, multi-modality2026-06-19
    Product approval · Class 3제허 26-465 호
  • MFDSFocused ultrasound stimulator system2026-03-18
    Product approval · Class 3제허 26-208 호
  • MFDSDiathermy treatment system operator console, high frequency2026-01-14
    Product approval · Class 3제허 26-44 호
  • FDACuRAS hybrid2025-11-20
    510(k) · TraditionalGeneral, Plastic SurgeryK253123
  • MFDSElectrosurgical system electrode, foot-controlled, single-use2024-06-24
    Product approval · Class 2제인 24-622 호
  • MFDSElectrosurgical system, general-purpose2024-05-17
    Product approval · Class 3제허 24-342 호
  • MFDSOphthalmic image, analysis softwareRevoked2024-05-16
    Product approval · Class 2제인 24-484 호
  • MFDSElectrode, external2024-05-03
    Product approval · Class 1수신 24-794 호
  • FDAVolnewmer™2024-04-29
    510(k) · TraditionalGeneral, Plastic SurgeryK240248
  • MFDSGel for medical use, non-sterilized2024-04-22
    Product approval · Class 1제신 24-494 호
Show 68 more
  • MFDSLaser surgical unit, diode2024-03-13
    Product approval · Class 3제허 24-189 호
  • MFDSFundus cameraRevoked2024-02-21
    Product approval · Class 2제인 24-187 호
  • FDASCIZER (SC1-M410)2023-11-03
    510(k) · TraditionalGeneral, Plastic SurgeryK230100
  • MFDSGel for medical use, non-sterilized2023-09-07
    Product approval · Class 1제신 23-1352 호
  • MFDSRadiation shield, spectacles2023-05-26
    Product approval · Class 1수신 23-1337 호
  • MFDSRadiation shield, spectacles2023-02-24
    Product approval · Class 1수신 23-327 호
  • MFDSElectrode, external2023-02-24
    Product approval · Class 1제신 23-222 호
  • MFDSElectrosurgical system electrode, foot-controlled, single-use2022-09-13
    Product approval · Class 2제인 22-4656 호
  • MFDSElectrode, external2022-08-04
    Product approval · Class 1제신 22-1090 호
  • MFDSElectrosurgical system, general-purpose2022-08-01
    Product approval · Class 3제허 22-512 호
  • MFDSGel for medical use, non-sterilized2022-06-16
    Product approval · Class 1제신 22-815 호
  • MFDSGuide for medical use2022-05-06
    Product approval · Class 1제신 22-622 호
  • MFDSGel for medical use, non-sterilized2022-05-02
    Product approval · Class 1제신 22-593 호
  • MFDSGuide for medical use2022-04-29
    Product approval · Class 1제신 22-587 호
  • MFDSLaser, surgical, Nd:YAG2022-04-15
    Product approval · Class 3제허 22-251 호
  • MFDSRadiation shield, spectacles2022-03-17
    Product approval · Class 1수신 22-455 호
  • MFDSLaser surgical unit, diode2022-03-11
    Product approval · Class 3제허 22-160 호
  • MFDSLaser, surgical, Nd:YAG2022-03-07
    Product approval · Class 3제허 22-148 호
  • MFDSElectrosurgical system electrode, hand-controlled, general-purpose, single-use2022-01-27
    Product approval · Class 2제인 22-4061 호
  • MFDSFocused ultrasound stimulator system2021-10-06
    Product approval · Class 3제허 21-831 호
  • MFDSPhototherapy unit, infraredRevoked2021-10-01
    Product approval · Class 2제인 21-4842 호
  • MFDSThermometer, electronic, infrared, skinRevoked2021-09-02
    Product approval · Class 2제인 21-4765 호
  • MFDSElectrosurgical system electrode, foot-controlled, reusableRevoked2021-09-01
    Product approval · Class 2제인 21-4760 호
  • MFDSSuction system, general-purpose, line-powered2021-08-19
    Product approval · Class 2제인 21-4720 호
  • MFDSSkin surface treatment system generator, multi-modalityRevoked2021-08-10
    Product approval · Class 3제허 21-676 호
  • MFDSGel for medical use, non-sterilizedRevoked2021-06-11
    Product approval · Class 1제신 21-854 호
  • MFDSPhototherapy unit, infraredRevoked2021-05-06
    Product approval · Class 2제인 21-4387 호
  • MFDSFundus cameraRevoked2021-04-13
    Product approval · Class 2제인 21-4293 호
  • MFDSElectrosurgical system, general-purpose2021-02-22
    Product approval · Class 3제허 21-133 호
  • MFDSGel for medical use, non-sterilizedRevoked2020-11-17
    Product approval · Class 1제신 20-1668 호
  • MFDSFocused ultrasound stimulator systemRevoked2020-05-18
    Product approval · Class 3제허 20-372 호
  • MFDSLaser, surgical, Nd:YAGRevoked2020-01-31
    Product approval · Class 3제허 20-66 호
  • MFDSLaser surgical unit, diodeRevoked2020-01-28
    Product approval · Class 3제허 20-53 호
  • MFDSElectrosurgical system electrode, foot-controlled, single-use2020-01-16
    Product approval · Class 2제인 20-4033 호
  • MFDSLaser surgical unit, diodeRevoked2019-12-03
    Product approval · Class 3제허 19-789 호
  • MFDSElectrode, external2019-11-15
    Product approval · Class 1제신 19-1491 호
  • MFDSLaser surgical unit, diode2019-11-07
    Product approval · Class 3제허 19-708 호
  • MFDSRadiation shield, spectacles2019-10-02
    Product approval · Class 1수신 19-2504 호
  • MFDSTrephine system, electrically-poweredRevoked2019-05-15
    Product approval · Class 2제인 19-4393 호
  • MFDSFocused ultrasound stimulator system2019-04-03
    Product approval · Class 3제허 19-201 호
  • MFDSFocused ultrasound stimulator systemRevoked2019-03-28
    Product approval · Class 3제허 19-192 호
  • MFDSSuction system, general-purpose, line-powered2019-03-08
    Product approval · Class 2제인 19-4170 호
  • MFDSRadiation shield, spectacles2019-03-08
    Product approval · Class 1수신 19-541 호
  • MFDSCooling2019-01-29
    Product approval · Class 2제인 19-4072 호
  • MFDSCooling2019-01-03
    Product approval · Class 2제인 19-4003 호
  • MFDSAbrasive device2018-12-21
    Product approval · Class 1제신 18-1711 호
  • MFDSLaser surgical unit, diodeRevoked2018-05-18
    Product approval · Class 3제허 18-368 호
  • MFDSElectrosurgical system, general-purpose2018-03-22
    Product approval · Class 3제허 18-190 호
  • MFDSInfusion pump, electrically-poweredRevoked2018-03-06
    Product approval · Class 2제인 18-4166 호
  • MFDSAbrasive device2018-02-20
    Product approval · Class 1제신 18-217 호
  • MFDSLaser surgical unit, diodeRevoked2018-02-13
    Product approval · Class 3제허 18-90 호
  • MFDSTrephine system, electrically-poweredRevoked2018-02-13
    Product approval · Class 2제인 18-4112 호
  • MFDSSuction system, general-purpose, line-powered2018-01-19
    Product approval · Class 2제인 18-4046 호
  • MFDSSystem, medical image processing device2017-12-18
    Product approval · Class 1제신 17-1420 호
  • MFDSLight, examination, mobile2017-12-14
    Product approval · Class 1제신 17-1412 호
  • MFDSLaser surgical unit, diodeRevoked2017-11-21
    Product approval · Class 3제허 17-884 호
  • MFDSMicroscope, light, ophthalmic, slit2017-11-16
    Product approval · Class 1제신 17-1314 호
  • MFDSElectrosurgical system electrode, foot-controlled, single-use2017-09-11
    Product approval · Class 2제인 17-4716 호
  • MFDSLaser surgical unit, diodeRevoked2017-09-01
    Product approval · Class 3제허 17-671 호
  • MFDSDirect infusion deviceRevoked2017-06-26
    Product approval · Class 2제인 17-4506 호
  • MFDSElectrosurgical system electrode, foot-controlled, single-use2017-05-02
    Product approval · Class 2제인 17-4314 호
  • MFDSFocused ultrasound stimulator system2017-04-10
    Product approval · Class 3제허 17-256 호
  • MFDSInfusion pump, electrically-poweredRevoked2017-04-04
    Product approval · Class 2제인 17-4251 호
  • MFDSDiathermy treatment system operator console, high frequency2017-03-09
    Product approval · Class 3제허 17-173 호
  • MFDSLaser, therapeuticRevoked2017-01-25
    Product approval · Class 3제허 17-78 호
  • MFDSLaser surgical unit, diodeRevoked2017-01-13
    Product approval · Class 3제허 17-39 호
  • MFDSFundus cameraRevoked2016-08-12
    Product approval · Class 2제인 16-4669 호
  • MFDSLaser surgical unit, diodeRevoked2016-08-11
    Product approval · Class 3제허 16-598 호

Showing the 80 most recent of 125 records.

Global clinical trials

ClinicalTrials.gov · sponsor-matched

Key disclosures

KRX KIND via OpenDART

Publications

PubMed · affiliation-matched

Patents

KIPRIS · applicant-matched
Show 231 more patents

AI reads

MAA server logs · IP-verified
168
Times AI engines pulled CLASSYS Inc.'s records

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23
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Last 7 days
131
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Last 30 days
168
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All time
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  • GoogleGoogleOther15
  • PerplexityPerplexityBot12
  • MicrosoftBingbot7
  • AnthropicClaudeBot2

Measured since Aug 26, 2026 · 5 AI engines · last read Oct 9, 2026

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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.

WON TECH CO.,Ltd.21 shared

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

Hironic Co.,Ltd16 shared

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

BTB Korea Co.,Ltd14 shared

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

ASTERASYS Co., Ltd.9 shared

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

REMED CO.,LTD.7 shared

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

SHINHUNG CO.,LTD6 shared

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

SEJONG MEDICAL Co.Ltd.,6 shared

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

MEDIANA Co.,LTD6 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.

DONG-A ST CO.,LTD6 shared

Dong-A ST, spun off from Dong-A Socio Holdings in 2013 and KOSPI-listed, makes prescription drugs like Growtropin, Stillen, and Bacchus.

WonIk Co.,LTD5 shared

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

Dynamic solution Co.,Ltd.5 shared

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

Alpha AI Co.,Ltd.4 shared

Alpha AI, founded in 1995 and KOSDAQ-listed in 2000, manufactures biocompatible metal implants and surgical instruments.

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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