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Medical DevicesKOSDAQ 19955028 approvals

Laseroptek Co., Ltd.

Official website

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

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Business overview

Source: DART corporate disclosure

Founded in 2000 and listed on KOSDAQ in 2024, Laseroptek is a medical device company specializing in laser-based aesthetic and disease-treatment devices. It launched the LOTUS and HELIOS laser aesthetic devices in 2005, obtained U.S. FDA and European CE certification for the LOTUS II and HELIOS II in 2009, and developed the PALLAS vitiligo treatment device based on a titanium-sapphire (Ti:Sapphire) 311nm solid-state UVB laser in 2016. It has developed products including PicoLO PREMIUM (2019-2020), HELIOS IV 785 (2019-2021), PALLAS PREMIUM (2019-2022), SCULPIO (2023-2024), and RAMAN LASER (2022-2026), and received KRW 10 billion in government funding under the Medical Device Standard Platform Technology Development and Dissemination Support Project from 2016 to 2021.

Products & technology

  • LOTUSLaser-based skin aesthetic device
  • HELIOSLaser-based skin aesthetic device
  • LOTUS II / HELIOS IILaser-based skin aesthetic device for export
  • PALLASTitanium-sapphire 311nm solid-state UVB laser-based vitiligo treatment device
  • PicoLO PREMIUMPicosecond laser aesthetic device
  • HELIOS IV 785785nm picosecond-pulse multi-wavelength laser aesthetic device
  • PALLAS PREMIUMNarrowband UVB laser treatment device
  • SCULPIOLaser aesthetic device with sculpting function
  • RAMAN LASER589nm-wavelength laser device for treating vascular disease

Regulatory approvals

data.go.kr · openFDA

17 Korean MFDS device approvals · 2003–2026 / 11 US FDA 510(k) · 2016–2025

  • MFDSLaser, surgical, Nd:YAG2026-02-24
    Product approval · Class 3제허 26-148 호
  • FDAHELIOS 785 Pico (1754V2)2025-02-07
    510(k) · TraditionalGeneral, Plastic SurgeryK243780
  • FDAHELIOS 785 Pico2023-05-22
    510(k) · TraditionalGeneral, Plastic SurgeryK230373
  • FDAPALLAS Premium2023-01-26
    510(k) · TraditionalGeneral, Plastic SurgeryK223588
  • MFDSLaser, surgical, Nd:YAG2022-06-21
    Product approval · Class 3제허 22-404 호
  • FDAHELIOS IV 7852022-06-09
    510(k) · TraditionalGeneral, Plastic SurgeryK212663
  • FDAPicoLO Premium2021-12-08
    510(k) · SpecialGeneral, Plastic SurgeryK212573
  • MFDSLaser, surgical, Nd:YAG2021-05-04
    Product approval · Class 3제허 21-349 호
  • FDAPicoLO Nd: YAG Picosecond Laser System2021-04-07
    510(k) · SpecialGeneral, Plastic SurgeryK203491
  • FDAPALLAS 308/311 Solid-State UV Laser System2020-01-03
    510(k) · SpecialGeneral, Plastic SurgeryK191501
  • FDAPicoLO Nd:YAG Picosecond Laser System2019-01-04
    510(k) · TraditionalGeneral, Plastic SurgeryK183392
  • FDALotus III Multi-Pulsed Er: Yag Laser System2018-12-27
    510(k) · TraditionalGeneral, Plastic SurgeryK182045
Show 16 more
  • MFDSLaser, surgical, Nd:YAG2018-08-06
    Product approval · Class 3제허 18-557 호
  • MFDSLaser, surgical, Nd:YAGRevoked2017-12-19
    Product approval · Class 3제허 17-958 호
  • FDAPALLAS 308/311 Solid-State UV Laser System2017-11-03
    510(k) · TraditionalGeneral, Plastic SurgeryK172639
  • FDAHelios III2016-06-02
    510(k) · TraditionalGeneral, Plastic SurgeryK152856
  • MFDSLaser, surgical, Nd:YAGRevoked2016-05-13
    Product approval · Class 3제허 16-358 호
  • MFDSLaser, surgical, Nd:YAGRevoked2015-12-15
    Product approval · Class 3제허 15-1675 호
  • MFDSLaser surgical unit, others2015-10-26
    Product approval · Class 3제허 15-1519 호
  • MFDSLaser, surgical, Nd:YAG2015-01-16
    Product approval · Class 3제허 15-69 호
  • MFDSLaser surgical unit, alexandriteRevoked2014-12-29
    Product approval · Class 3제허 14-3289 호
  • MFDSLaser, surgical, Nd:YAG2013-08-29
    Product approval · Class 3제허 13-1491 호
  • MFDSLaser, surgical, Nd:YAG2012-02-07
    Product approval · Class 3제허 12-163 호
  • MFDSLaser, surgical, Nd:YAGRevoked2009-07-21
    Product approval · Class 3제허 09-545 호
  • MFDSLaser, surgical, carbon dioxideRevoked2009-07-21
    Product approval · Class 3제허 09-544 호
  • MFDS레이저수술기Revoked2007-09-21
    Product approval · Class 3제허 07-529 호
  • MFDS레이저수술기Revoked2007-05-04
    Product approval · Class 3제허 07-252 호
  • MFDS레이저수술기Revoked2003-08-11
    Product approval · Class 2제허 03-698 호

R&D and key agreements

Source: DART corporate disclosure

PicoLO PREMIUM · 개발완료(2019.04~2020.09) · Development adding an HP module and improving stability

HELIOS IV 785 · 개발완료(2019.01~2021.04) · Development of 785nm picosecond-pulse, multi-wavelength laser

PALLAS PREMIUM · 백반증 · 개발완료(2019.01~2022.06) · Development of narrowband UVB laser

SCULPIO · 개발(2023.01~2024.12) · Development of laser device with added sculpting function

RAMAN LASER · 혈관성 질환 · 개발(2022.05~2026.04) · Development of 589nm laser for vascular disease treatment

의료기기 표준 플랫폼 기술개발 및 보급활성화 지원사업 · 완료(2016.12~2021.11) · Led by Keimyung University; Laseroptek among 5 participating institutions; KRW 10 billion government funding; related to PALLAS and HELIOS

경기도 기술개발사업(300Hz 308/311nm 자외선 단일모드 고체레이저 의료기기) · 완료(2021.06~2022.05) · Supported by Gyeonggi-do Economic Science Promotion Agency; KRW 150 million; sole lead; related to PALLAS premium

해외규격인증획득지원사업 · 완료(2021.04~2023.04) · Supported by Ministry of SMEs and Startups; KRW 68 million; sole lead; overseas certification for HELIOS IV and PALLAS premium

Not yet compiled: business overview. Send us materials and we will add them

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.6 shared

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

CLASSYS Inc.4 shared

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

BTB Korea Co.,Ltd3 shared

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

Hironic Co.,Ltd3 shared

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

Dynamic solution Co.,Ltd.2 shared

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

JETEMA Co.,Ltd.2 shared

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

SHINHUNG CO.,LTD2 shared

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

DENTIS CO.,LTD1 shared

Founded in 2016 and listed on KOSDAQ in 2017, DENTIS manufactures dental implants, medical LED lighting, and dental 3D printers.

DONG-A ST CO.,LTD1 shared

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

LAMEDITECH Co., Ltd.1 shared

KOSDAQ-listed medical device company developing skin aesthetic devices and laser blood-sampling devices based on compact high-power laser technology.

T&L Co., LTD.1 shared

Established in 1998 and listed on KOSDAQ in 2020, T&L manufactures wound dressings, microneedles, and orthopedic fixation products.

ValueAddedTechnologyCo.,Ltd.1 shared

Founded in 1992 and KOSDAQ-listed in 2006, VATECH manufactures dental digital X-ray and CT imaging diagnostic devices.

Sources and updates

Company basics
Korea Exchange · DART
Business content
Compiled from disclosure filings
AI visibility
Measured 2026-08-13

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