Instruments for functional explorations and therapeutic interventionsGeneral and multidisciplinary surgery instruments
Laser surgery instruments
EMDN code Z120110
Manufacturers registered in Europe (EUDAMED) 90
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
- Click a manufacturer to see its full range, a model to open its EUDAMED record.
A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.
Other manufacturers known in the United States (FDA) 424
Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.
| Manufacturer | Country | Brands | FDA clearance |
|---|---|---|---|
| Laser Peripherals, LLC | United States | FS-365 RB-272-PL LG-365-CNE DB-600-D HB-940-PL FS-150 | K170366 (2017) |
| Iridex Corp Present in Europe in other categories | United States | PASCAL Synthesis, 532nm PASCAL Synthesis, 577nm OMA (810 nm) Cyclo G6 Laser Console IQ577 Laser Console IQ532 Laser Console | K181662 (2018) |
| Alma Lasers, Inc. Present in Europe in other categories | United States | FemiLift Sleeve NIR Module Diode 810nm Handpiece for Soprano Diode 810nm 1.2 cm2 HP Sinon Ruby Laser System (silver) Diode Alex 755nm 1.5cm HP Soprano Ice & Xli | K250071 (2025) |
| Innovaquartz, LLC | United States | ProFlex™ ProFlex Dornier Thulio Performance Fiber MegaJOULE LDD™ | K233157 (2024) |
| OPHTHALMED LLC | United States | – | K021696 (2002) |
| Convergent Laser Technologies | United States | Optilite | K211517 (2021) |
| CAO Group, Inc. Present in Europe in other categories | United States | Precise SHP 600um Fiber Tip Pioneer Elite Perio Tip Precise SHP 300um Fiber Tip Pioneer Elite Standard Fiber Tip Precise SHP Display Stand Precise SHP 200um Fiber Tip | K254197 (2026) |
| Omniguide, Inc. | United States | GYN-LAP Handpiece, 33cm, Bent Velocity™ High Performance Fiber FlexGuide ULTRA with Tray Elevate™ENT Handpiece 22cm 45°/15° -S OMNIGUIDE BeamPath OTO-U Fiber GYN Handpiece Mark III, 6 cm | K230819 (2023) |
| Trimedyne, Inc. | United States | Trimedyne® VaporMax® - Ho:YAG Side Firing Handpiece Trimedyne® FlexMax® 550 µm Reusable Holmium Bare Fiber (SMA Connector) Trimedyne® FlexMax® 200 µm Reusable Holmium Bare Fiber, 5m Length Trimedyne® FlexMax® 272 µm Reusable Fiber (SMA Connector) Trimedyne® FlexMax® 10000 µm Reusable Holmium Bare Fiber (SMA Connector) Trimedyne® OmniTip™ Switchable Tip - SJ-50 mm Straight | K053457 (2005) |
| Jeisys Medical, Inc. Present in Europe in other categories | South Korea | SMOOTHCOOL Filter TRI-BEAM PRO Handpiece TRI-BEAM Handpiece Edge Guide Tip SMOOTHCOOL Handpiece Edge Handpiece | K251464 (2025) |
| Solta Medical, Inc. Present in Europe in other categories | United States | Isolaz Fraxel Fraxel FTX Fraxel re:store DUAL Laser System Clear & Brilliant CLEAR+BRILLIANT TOUCH | K242142 (2024) |
| Lightscalpel, LLC | United States | LightScalpel | K213669 (2023) |
| IPG Medical Corporation | United States | Thuvera IPG Medical LUROS Regenalase Soltive Gemini | K251100 (2025) |
| DEN-MAT HOLDINGS, LLC | United States | SOL® STERLING® NV® BLUEWAVE SL3® NV®PRO3 | K110079 (2011) |
| Peregrine Surgical , Ltd. | United States | 20GA Straight Laser Probe, SMA905 20GA Curved Laser Probe, SMA905 25GA Straight Laser Probe, SMA905 25GA Curved Laser Probe, SMA905 23GA Curved Laser Probe, SMA905 23GA Straight Laser Probe, SMA905 | K024061 (2003) |
| Gyrus Acmi, Inc. Present in Europe in other categories | United States | SOLTIVE Olympus | K221306 (2023) |
| MAXIFLEX, LLC | – | MaxiFlex Holmium Laser Fiber | registered |
| TELEFLEX INCORPORATED Present in Europe in other categories | United States | VARI-LASE VSI | registered |
| Cook, Inc. | United States | Cook Optilite Rhapsody H-30 Odyssey 30 | K181431 (2018) |
| Ilooda Co,., Ltd. | South Korea | CuRAS Main Head CuRAS Collimation H/P Fraxis 1.1 Main Unit reepot Main Unit CuRAS Main Unit VIKINI Main Unit | K241699 (2024) |
| AZENA MEDICAL, LLC | United States | Gemini EVO Gemini Gemini Nova Power Supply - US Nova Shipping Box Gemini Nova PBM 7 mm Tip Barrier Sleeve (50 pk) | K192617 (2020) |
| Dawell Medical, LLC | United States | Lithoblast Single-Use Holmium Laser Fibers | K250776 (2025) |
| LEONI Fiber Optics GmbH | United States | FiberTech® CoolLipoTM | K201171 (2021) |
| WISDOM MEDICAL TECHNOLOGY, LLC | – | MegaBeam Duster Twister Twister L Twister XXL FLA | registered |
| FORTEC FIBERS, INC. | – | – | registered |
| Monteris Medical, | United States | NeuroBlate Optic FullFire® Laser Probe NeuroBlate Optic SideFire® Laser Probe NeuroBlate® System NeuroBlate NB3 FullFire™ 1.6 Laser Probe FullFire® Select Diffusing Tip Laser Probe NeuroBlate® Robotic Probe Driver | K231061 (2023) |
| Light Instruments | Israel | TIP for LITETOUCH D-STORM LiteTouch Straight Handpiece, LT LiteTouch Applicator E1 Handpiece, LT | K093048 (2010) |
| Viora , Ltd. | Israel | V-IPL Optic set Full 6 filters V-IPL Filter SR-580 V30 Console V-Nd:YAG Spot 2x4 mm² V-IPL Small Spot V-IPL Optic set Full | K162363 (2016) |
| ACQUIRE MED | – | Acquire Med LEONI™ | registered |
| AngioDynamics, Inc. | United States | VenaCure EVLT VenaCure | K231945 (2023) |
| C.R. Bard, Inc. | United States | EndoBeam™ Holmium Laser Fiber Elyra | K252971 (2026) |
| Ellipse A/S | Denmark | Ellipse HRL 600 HRD 645 Frax 1550 Ellipse Nordlys Ellipse Sirius | K192951 (2020) |
| ESPANSIONE MARKETING SPA Present in Europe in other categories | Italy | E-LIGHT LINE EPI-C PLUS | K092734 (2010) |
| Topcon Medical Laser Systems, Inc. | United States | PASCAL Synthesis PACSAL Synthesis PASCAL Synthesis TwinStar | K043486 (2005) |
| Clinicon Corp. | United States | SureProbe SureGuide SureBlade SureTouch SureScan SureTip | K121580 (2012) |
| SIE AG, Surgical Instrument Engineering | Switzerland | Procedure Pack FEMTO LDV | K053511 (2006) |
| LAMBDA SPA | Italy | Doctor Smile Doctor Diode Laser | K102036 (2010) |
| INTERNATIONAL MEDICAL LASERS, INC. | – | HMR-365A HMR-200A HMR-272A HM-272A-DT HMR-1000 HM-200A-DT | registered |
| Strata Skin Sciences, Inc. | United States | XTRAC VTRAC TheraClear | K193478 (2020) |
| Vascular Solutions, Inc. Present in Europe in other categories | United States | Vari-Lase® Platinum Bright Tip laser fiber and procedure kits Vascular Solutions Custom Access Kit Vari-Lase® Platinum Bright Tip laser fiber Vari-Lase® Flex laser fiber and procedure kits | K113140 (2011) |
| PROCTER & GAMBLE MANUFACTURING COMPANY, THE | – | Braun Silk.expert Pro 5 Braun Silk.expert Pro 3 Braun Skin i-expert Braun Silk.expert Mini | registered |
| VYDENCE MEDICAL Present in Europe in other categories | Brazil | handPICO 3-24/hr SIBERIAN-FIT 3-10/vl 5-15/lt ZYE-ULTRA FDA | K242534 (2024) |
| Venus Concept USA, Inc. | United States | Venus Velocity Venus Versa - SR580 light block package Venus Versa - SR515 light block package Venus Versa - HR650 light block package Medium Light Guide Venus Versa - HR 650XL light block package | K200786 (2020) |
| Inmode MD , Ltd. | Israel | InMode Diolaze XL 810/1064 Applicator Plus Applicator VLaze Applicator VasculazeMAX Applicator Envision System | K180719 (2018) |
| LAZON Medical Laser Co., Ltd. | China | Dental Diode Laser System | K180967 (2018) |
| American Medical Systems | United States | GreenLight HPS Aura XP GreenLight XPS XPS and HPS SureFlex | K140679 (2014) |
| COASTAL LIFE TECHNOLOGIES, INC. | – | Surgimedics® | registered |
| Tria Laser Inc | United States | HAIR REMOVAL LASER Hair Removal Laser Precisison Smooth Beauty Laser Smooth Beauty Eye Wrinkle Laser Skin Renu Laser | registered |
| AMERICAN MEDICAL ENDOSCOPY, INC. | United States | Strauss Surgical | registered |
| Shandong Huamei Technology Co.,Ltd. Present in Europe in other categories | China | Huamei | K162659 (2017) |
| ADLER MICROMED, INC. | United States | Adler MicroMed Laser Surgery Fiber Adler MicroMed Laster Surgery Fiber | K152417 (2015) |
| FORMATK SYSTEMS LTD Present in Europe in other categories | Israel | DioBreeze ND Alpha HR-Max Magma LLD | K183307 (2018) |
| Vortex Surgical, Inc. | United States | 23ga Flexible Tapered Laser Probe - Alcon Compatible 27ga Curved Laser Probe - Iridex Compatible 25ga Straight Laser Probe - Alcon Compatible 20ga Curved Laser Probe - Alcon Compatible 20ga Flexible Tapered Laser Probe - Alcon Compatible 25ga Flexible Tapered Laser Probe - Iridex Compatible | registered |
| Coloplast Corp. | United States | Coloplast | K182831 (2018) |
| Laser Engineering, Inc. | United States | Laser Engineering UltraLase Flexible Laser Waveguide Imperium | K211605 (2022) |
| HYPER PHOTONICS SRL | Italy | Re-Usable surgical optical fiber Single use surgical optical fiber O35 HYPHO | K163449 (2017) |
| Medtronic Navigation, Inc. Present in Europe in other categories | United States | Visualase StealthStation | registered |
| Zimmer Medizinsysteme GmbH Present in Europe in other categories | Germany | Cryo 6 Cryo-C Cryo 7 CryoMini CryoOne | K220020 (2022) |
| Wingderm Electro-Optics Ltd. | China | Lasermach Renuva 1550 | K252599 (2026) |
| BENCO DENTAL SUPPLY CO. | – | STERLING | registered |
| Innovoyce LLC | United States | InnoVoyce Laser Fiber InnoVoyce VYLO Eye Safety Filter Zeiss InnoVoyce VYLO Laser InnoVoyce VYLO Cart InnoVoyce VYLO Eye Safety Filter Leica InnoVoyce VYLO Footswitch | K240159 (2024) |
| Moor Instruments, Ltd. Present in Europe in other categories | United Kingdom | Moor Instruments Ltd moorVMS-VASC PC Software moorVMS-PC Software moorVMS-TREND PC Software | K083082 (2009) |
| Peter Brasseler Holdings, LLC | United States | BLU | registered |
| Advanced Technology Laser Co., Ltd. | China | ATL | K140249 (2014) |
| Bison Medical Co, Ltd. | South Korea | ACCENTO RUBY STAR CYMA LUCID LY LUCID Q-PTP | K161670 (2016) |
| Clarus Medical, LLC | United States | LASE Endoscopic Discectomy Set LASE Curved Operating Channel Set LASE Accessory Kit | K040424 (2004) |
| Foreo AB | – | PEACH 2 go PEACH 2 PEACH 2 pro max PEACH 2 duo | registered |
| Nanjing Bestview Laser S&T Co., Ltd. | China | BVLASER | K260974 (2026) |
| Sharplight Technologies, Ltd. | Israel | OMNIMAX S3 Rapid QS Rapid DPC Rapid Peel Rapid Tight Rapid Vanish | K233304 (2023) |
| Synergetics, Inc. | United States | PHOTON | K990568 (1999) |
| TRIANGEL RSD LIMITED | China | Triangel | K212734 (2023) |
| ACTIVE OPTICAL SYSTEMS LTD Present in Europe in other categories | Israel | Spirit Optima Crystal Extra Sheerwave | K153718 (2016) |
| Acuderm, Inc. Present in Europe in other categories | United States | ACU-GUARD | K915000 (1992) |
| FIBER OPTIC FABRICATIONS, INC. | United States | LithoWise SideWise | K120810 (2012) |
| Philips Consumer Lifestyle B.V. Present in Europe in other categories | United States | Philips Lumea IPL | registered |
| Sciton, Inc | United States | mJoule BBLs Joule Diva System JOULE | K251077 (2025) |
| TYPENEX MEDICAL LLC Present in Europe in other categories | United States | Fibernex Fibernex Laser System | registered |
| Advance-Esthetic LLC | United States | Zemits DuoCratus Zemits CarbonFrax Pro Zemits DioPulse Zemits YAGenix Zemits Quidion | registered |
| Beijing Sano Lasers S&T Development Co., Ltd. | – | SANO | registered |
| Ddc Technologies, Inc. | United States | Polylase EPY-50 AL-40 | K253765 (2026) |
| JOHNSON & JOHNSON SURGICAL VISION, INC. Present in Europe in other categories | United States | FS DISPOSABLE INTERFACE FS LASER SYSTEM INTRALASE FS FEMTOSEC LASER IFS ADVANCED FEMTOSEC LASER | registered |
| RAJA Medical | – | OXYLIGHT | registered |
| Rhein Laser Technologies Co., Ltd. | China | Artemis Diode Laser System Medical Thulium Fiber Laser Systems TitanPico Laser Workstation | K261738 (2026) |
| SHENZHENSHI SINCOHEREN S&T DEVELOPMENT CO.,LTD | China | LED Spectrum therapy instrument | K231894 (2023) |
| Shenzhen Gsd Tech Co., Ltd. Present in Europe in other categories | China | GSD | K213225 (2021) |
| Alcon Laboratories, Inc. Present in Europe in other categories | United States | WaveLight Wave Light FS200 EASYPACK Eyelite, PurePoint, Alcon Alcon | K190392 (2019) |
| Beijing Nubway S&T Co., Ltd. | China | Nubway Diode Laser Hair Removal machine Q Switched Nd:YAG Laser machine | K261692 (2026) |
| Canadian Pioneer Medical Technology Corporation | Canada | TORLASE-Alexandrite and Nd: Yag laser CANLASE-Alexandrite and Nd: Yag laser PureLase CPMT Ares – Quadruple Laser System | K211722 (2022) |
| Gme German Medical Engineering GmbH Present in Europe in other categories | Germany | LinScan C + B Pelo TwinScan 808/755 Laser System FlexSys | K221623 (2023) |
| Hydrafacial LLC Present in Europe in other categories | United States | Del Sol Blue Light Therapy System | registered |
| I.C Medical, Inc. Present in Europe in other categories | United States | Speculum Tubing | K930098 (1993) |
| Jiangxi Medex Technology Co., Ltd. | China | SLT medex LaserPro | K243141 (2024) |
| LOTUS GLOBAL GROUP, INC, THE | – | OMNILUX | registered |
| MDElite Laser and Aesthetic, LLC | – | iLightPro MDElite iProX MD Elite LaserPro iProElite | registered |
| Medical San Indústria DE Equipamentos Médicos Ltda. | Brazil | Medical San | K241771 (2024) |
| Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd Present in Europe in other categories | China | SWOT | K243037 (2024) |
| Starmedtec GmbH | Germany | – | K121570 (2013) |
| Aesthetic Technology, Ltd. Present in Europe in other categories | United Kingdom | Dermalux | K240222 (2024) |
| Beijing Superlaser Technology Co., Ltd. | China | SUPERLASER | K251457 (2025) |
| LASETECH LLC | United States | EpiCare-Zenith | registered |
The 100 most active manufacturers are shown, out of 424.
Didn't find it?
Tell us what you are looking for. Requests show us which categories to add first.
Related categories
- Cleaning, disinfection and sterilisation instruments143 manufacturers
- Various instruments for general and multidisciplinary surgery128 manufacturers
- Patient positioning instruments121 manufacturers
- Electrosurgical instruments86 manufacturers
- Scialytic lamp lighting systems82 manufacturers
- Surgical medical aspirators46 manufacturers
- Instruments for operative microscopy44 manufacturers
- Surgical navigation instruments31 manufacturers
- Cryosurgery equipment21 manufacturers
- Instruments for ultrasonic surgery17 manufacturers
- Dermotomy equipment5 manufacturers
- Self-transfusion equipment4 manufacturers
- Parent category : General and multidisciplinary surgery instruments696 manufacturers