Instruments for functional explorations and therapeutic interventionsGeneral and multidisciplinary surgery instrumentsLaser surgery instruments
Laser surgery instruments - hardware accessories
EMDN code Z12011080
Manufacturers registered in Europe (EUDAMED) 23
- 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) 47
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 |
|---|---|---|---|
| Cynosure, Inc. Present in Europe in other categories | United States | Max G Handpiece Max Rs Handpiece Max Ys Handpiece 1064+ Handpiece Emerge Handpiece Max R Handpiece | registered |
| Solta Medical, Inc. Present in Europe in other categories | United States | Clear & Brilliant CLEAR+BRILLIANT TOUCH | K120433 (2012) |
| Jeisys Medical, Inc. Present in Europe in other categories | South Korea | Edge Guide Tip Edge Handpiece Footswitch Edge Edge ONE Edge Arm | registered |
| Ilooda Co,., Ltd. | South Korea | Fraxis 1.1 Main Unit Secret DUO Laser Handpiece Secret DUO Main Unit Secret DUO Standard Handpiece Secret DUO Bigger Handpiece Fraxis 1.1 Set Package | registered |
| CLASSYS Inc. Present in Europe in other categories | South Korea | Secret DUO Main Unit Fraxis Zoom Handpiece Fraxis Handpiece Secret DUO Laser Handpiece Secret DUO Set Package Fraxis Set Package | registered |
| Tria Laser Inc | United States | Smooth Beauty Laser Smooth Beauty Eye Wrinkle Laser Skin Renu Laser | registered |
| Shanghai Apolo Medical Technology Co., Ltd. Present in Europe in other categories | China | Apolomed | K251031 (2025) |
| AVAVA, Inc. | United States | MIRIA | K252155 (2025) |
| Sciton, Inc | United States | mJoule JOULE | registered |
| Alma Lasers, Inc. Present in Europe in other categories | United States | EXELO2 CO2 Laser System | registered |
| Bison Medical Co, Ltd. | South Korea | CYMA | registered |
| Focus Medical, LLC Present in Europe in other categories | United States | Focus Medical | K110333 (2012) |
| Lasering S.R.L. Present in Europe in other categories | United States | LASERING SRL | K110984 (2011) |
| Rohrer Aesthetics, LLC | United States | Phoenix CO2 | registered |
| Weifang Mingliang Electronics Co., Ltd. Present in Europe in other categories | China | MLKJ | registered |
| Wingderm Electro-Optics Ltd. | China | Renuva 1550 | K192350 (2020) |
| ATENA (FROM THE IMCO GROUP) LTD | Israel | – | registered |
| Acclaro Corporation Present in Europe in other categories | United States | – | registered |
| Amt Engineering Co., Ltd. | South Korea | – | registered |
| BENCHMARK ELECTRONICS, INC. | United States | – | registered |
| BLUECORE COMPANY Co., Ltd. Present in Europe in other categories | South Korea | – | registered |
| Beijing Beautemax Technology Limited | China | – | registered |
| Beijing Perfectlaser Technology Co.,Ltd | China | – | registered |
| Beijing Sea Heart International Science And Technology Co.,L | China | – | registered |
| Beijing Sincoheren Science and Technology Development Co. Present in Europe in other categories | China | – | K162398 (2017) |
| Beijing Sincoheren Science and TechnologyDevelopment Co., Lt | China | – | registered |
| Beijing Spiritlaser Science & Technology Co., Ltd. | China | – | registered |
| Beijing Winkonlaser Technology Limited | China | – | registered |
| Cogmedix, Inc. | United States | – | registered |
| Currentbody Ltd. | United Kingdom | – | registered |
| E-SWIN Present in Europe in other categories | France | – | registered |
| El.En Electronic Engineering Spa | Italy | – | registered |
| Ids, Ltd. Present in Europe in other categories | South Korea | – | K180036 (2018) |
| Jiangsu Unimed Laser Technology Co., Ltd. | China | – | K182498 (2018) |
| Lutronic Aesthetic | United States | – | K233550 (2024) |
| Lutronic Aesthetics, Inc. | United States | – | registered |
| Megagen Implant Co. Ltd Present in Europe in other categories | South Korea | – | registered |
| Olemy Laser Technology LTD. | China | – | registered |
| Paradigm Medical Technologies Corporation | United States | – | registered |
| Paradigm Medical, Inc. | United States | – | K213332 (2022) |
| Quantel Medical Present in Europe in other categories | United States | – | registered |
| R. H. Electronics Ltd. | Israel | – | registered |
| SNJ Co., Ltd. Present in Europe in other categories | South Korea | – | registered |
| Sanhe Jumei Technology Co.,Ltd | China | – | registered |
| Sanmina Corporation | United States | – | registered |
| Sharplight Technologies, Ltd. | Israel | – | registered |
| Srmc Co., Ltd. | United States | – | K141046 (2014) |
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