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Medical DevicesKOSDAQ 21975059 approvals

BTB Korea Co.,Ltd

Official website

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

As of 2026-10-10, BTB Korea Co.,Ltd has 59 Korean MFDS device approvals on record (counted by the MAA Company Index from its own matching of public databases).

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Business overview

Source: DART corporate disclosure

Founded in 1999 and listed on KOSDAQ in 2018, BTB Korea is an aesthetic medical device company that took its current name in March 2024 when former GTG Wellness absorbed Donginbiotech in a merger. Its Medical Device Division manufactures anti-aging and lifting devices including the professional-use PICO and DUAL HI and personal-use Home Beauty Device (ODM) and LEBODY FORM, while its Bio Division distributes research reagents such as Biochemicals Antibody Kits. Its dual-transducer device reduced abdominal treatment time from about one hour to 30-40 minutes, and a 2015 Ministry of Trade, Industry and Energy 'Core Medical Device Commercialization Technology' project generated about KRW 1.9 billion in second-year commercialization revenue, earning the ministry's 'Industrial Technology Award of the Month.'

Products & technology

  • PICOprofessional-use aesthetic medical device
  • DUAL HIprofessional-use aesthetic device (dual-transducer HIFU)
  • Home Beauty Device (ODM)personal-use beauty device
  • LEBODY FORMpersonal-use beauty device
  • Biochemicals Antibody Kitbiotech research reagents and kits

Regulatory approvals

data.go.kr

59 Korean MFDS device approvals · 2006–2021

  • MFDSStatics electricity stimulator for medical use2021-01-20
    Product approval · Class 2제인 21-4041 호
  • MFDSDirect infusion deviceRevoked2020-05-15
    Product approval · Class 2제인 20-4376 호
  • MFDSDiathermy treatment system operator console, high frequency2020-03-26
    Product approval · Class 3제허 20-220 호
  • MFDSLaser surgical unit, diode2020-03-13
    Product approval · Class 3제허 20-181 호
  • MFDSInjector, medication/vaccine, needleless, gas-poweredRevoked2020-01-31
    Product approval · Class 2제인 20-4076 호
  • MFDSFocused ultrasound stimulator system2019-11-22
    Product approval · Class 3제허 19-746 호
  • MFDSLaser surgical unit, diode2019-05-22
    Product approval · Class 3제허 19-327 호
  • MFDSFocused ultrasound stimulator system2019-04-26
    Product approval · Class 3제허 19-271 호
  • MFDSLaser, surgical, Nd:YAG2019-01-17
    Product approval · Class 3제허 19-45 호
  • MFDSInjector, medication/vaccine, needleless, gas-powered2018-11-23
    Product approval · Class 2제인 18-4965 호
  • MFDSLaser, therapeutic2018-07-04
    Product approval · Class 3제허 18-474 호
  • MFDSLaser, surgical, Nd:YAGRevoked2018-06-26
    Product approval · Class 3제허 18-455 호
Show 47 more
  • MFDSLaser, surgical, Nd:YAGRevoked2018-04-11
    Product approval · Class 3제허 18-243 호
  • MFDSLaser, therapeutic2018-03-27
    Product approval · Class 3제허 18-199 호
  • MFDSElectrosurgical system electrode, foot-controlled, reusable2018-03-27
    Product approval · Class 2제인 18-198 호
  • MFDSElectrosurgical system, general-purpose2018-02-12
    Product approval · Class 3제허 18-85 호
  • MFDSLow frequency electric stimulator for medical use, home useRevoked2017-12-12
    Product approval · Class 2제인 17-4956 호
  • MFDSLaser, therapeuticRevoked2017-08-11
    Product approval · Class 3제허 17-617 호
  • MFDSFocused ultrasound stimulator system2017-07-17
    Product approval · Class 3제허 17-512 호
  • MFDSFocused ultrasound stimulator system2017-05-16
    Product approval · Class 3제허 17-317 호
  • MFDSInfusion pump, electrically-poweredRevoked2017-03-17
    Product approval · Class 2제인 17-4193 호
  • MFDSIontophoresis sweat induction systemRevoked2017-03-17
    Product approval · Class 2제인 17-4188 호
  • MFDSLaser, surgical, carbon dioxideRevoked2017-02-13
    Product approval · Class 3제허 17-107 호
  • MFDSElectrosurgical system, general-purposeRevoked2017-01-19
    Product approval · Class 3제허 17-59 호
  • MFDSSuction system, general-purpose, line-poweredRevoked2017-01-12
    Product approval · Class 2제인 17-4031 호
  • MFDSElectrosurgical system electrode, foot-controlled, reusableRevoked2017-01-09
    Product approval · Class 3제허 17-28 호
  • MFDSElectrode, external2017-01-04
    Product approval · Class 1제신 17-17 호
  • MFDSCombination stimulator, class 22016-11-28
    Product approval · Class 2제인 16-4887 호
  • MFDSInfusion pump, electrically-poweredRevoked2016-11-04
    Product approval · Class 2제인 16-4846 호
  • MFDSCombination stimulator, class 22016-10-17
    Product approval · Class 2제인 16-4803 호
  • MFDSDiathermy treatment system operator console, high frequencyRevoked2016-09-30
    Product approval · Class 3제허 16-727 호
  • MFDSHigh intensity focused Ultrasonic surgical system2016-05-25
    Product approval · Class 3제허 16-386 호
  • MFDSCombination stimulator, class 2Revoked2016-05-17
    Product approval · Class 2제인 16-4402 호
  • MFDSCombination stimulator, class 2Revoked2016-04-26
    Product approval · Class 2제인 16-4354 호
  • MFDSCombination stimulator, class 2Revoked2016-04-18
    Product approval · Class 2제인 16-4331 호
  • MFDSCombination stimulator, class 22016-04-07
    Product approval · Class 2제인 16-4308 호
  • MFDSSpeculum, vaginal, reusable2016-02-24
    Product approval · Class 1제신 16-201 호
  • MFDSHigh intensity focused Ultrasonic surgical systemRevoked2016-02-22
    Product approval · Class 3제허 16-131 호
  • MFDSLaser, surgical, carbon dioxideRevoked2016-02-04
    Product approval · Class 3제허 16-91 호
  • MFDSInfusion pump, electrically-poweredRevoked2016-02-01
    Product approval · Class 2제인 16-4096 호
  • MFDSLaser surgical unit, othersRevoked2016-01-29
    Product approval · Class 3제허 16-70 호
  • MFDSElectrosurgical system electrode, foot-controlled, single-useRevoked2016-01-11
    Product approval · Class 2제인 16-25 호
  • MFDSInfusion pump, electrically-poweredRevoked2015-11-25
    Product approval · Class 2제인 15-4307 호
  • MFDSHigh intensity focused Ultrasonic surgical systemRevoked2015-11-12
    Product approval · Class 3제허 15-1577 호
  • MFDSCoolingRevoked2015-11-02
    Product approval · Class 2제인 15-4235 호
  • MFDSElectrosurgical system, general-purposeRevoked2015-09-15
    Product approval · Class 3제허 15-1413 호
  • MFDSLaser surgical unit, diodeRevoked2015-07-08
    Product approval · Class 3제허 15-1115 호
  • MFDSHigh intensity focused Ultrasonic surgical system2015-04-01
    Product approval · Class 3제허 15-457 호
  • MFDSLaser surgical unit, diodeRevoked2015-03-17
    Product approval · Class 3제허 15-368 호
  • MFDSCombination stimulator, class 3Revoked2014-12-30
    Product approval · Class 3제허 14-3353 호
  • MFDSHigh intensity focused Ultrasonic surgical system2014-12-29
    Product approval · Class 3제허 14-3330 호
  • MFDSLaser, surgical, carbon dioxideRevoked2014-12-23
    Product approval · Class 3제허 14-3229 호
  • MFDSElectrosurgical system, general-purposeRevoked2014-06-23
    Product approval · Class 3제허 14-1210 호
  • MFDSHigh intensity focused Ultrasonic surgical system2014-03-31
    Product approval · Class 3제허 14-761 호
  • MFDSElectrosurgical system, general-purpose2013-05-27
    Product approval · Class 3제허 13-916 호
  • MFDSCombination stimulator, class 2Revoked2010-05-04
    Product approval · Class 2제인 10-440 호
  • MFDSIontophoresis sweat induction systemRevoked2008-10-06
    Product approval · Class 2제허 08-703 호
  • MFDSLaser surgical unit, diodeRevoked2008-02-28
    Product approval · Class 3제허 08-111 호
  • MFDS호기가스분석기Revoked2006-02-21
    Product approval · Class 2수허 06-184 호

R&D and key agreements

Source: DART corporate disclosure

듀얼 트랜스듀서 HIFU 장비 개발(핵심의료기기제품화기술사업) · 체형관리(복부 리프팅) · 완료 · Selected for 2015 MOTIE government project; 2-year execution; ~KRW 1.9 billion in second-year commercialization revenue; received the Ministry's 'Industrial Technology Award of the Month'

Key disclosures

KRX KIND via OpenDART

Patents

KIPRIS · applicant-matched
Show 28 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.14 shared

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

Hironic Co.,Ltd12 shared

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

WON TECH CO.,Ltd.11 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.

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.

Alpha AI Co.,Ltd.4 shared

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

SHINHUNG CO.,LTD3 shared

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

REMED CO.,LTD.3 shared

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

Laseroptek Co., Ltd.3 shared

KOSDAQ-listed medical device company developing the LOTUS and HELIOS laser aesthetic devices and the PALLAS vitiligo treatment device.

SEWOONMEDICAL CO,. LTD.3 shared

Founded in 1982 and KOSDAQ-listed in 2008, Sewoon Medical manufactures medical aspirators and catheters/tubes.

JETEMA Co.,Ltd.3 shared

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

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

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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