Instruments for functional explorations and therapeutic interventionsGeneral medicine instrumentsGeneral medicine therapeutic treatment instruments
Phototherapy equipment
EMDN code Z12040202
Manufacturers registered in Europe (EUDAMED) 42
- 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) 87
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 |
|---|---|---|---|
| FORMATK SYSTEMS LTD Present in Europe in other categories | Israel | iProElite Alpha Magma L-530 Forma Sheerwave Plus | K160195 (2016) |
| Solta Medical, Inc. Present in Europe in other categories | United States | Isolaz | K121515 (2012) |
| Lumenis Be, Ltd. Present in Europe in other categories | Israel | Stellar M22™ Stellar™ SapphireCool™ LG 15x35 Kit Stellar IPL™ HP Stellar M22™ IPL 695nm Filter Kit Stellar™ Stellar M22™ IPL Acne Filter Kit | registered |
| Alma Lasers, Inc. Present in Europe in other categories | United States | Alma SupErb ALMA HARMONY CONSOLE Iris SR IPL HP Iris SHR Pro (6.4) Cooled IPL HP Handpiece Cooled Dye VL (3) For HXL Iris Acne IPL HP | K181298 (2018) |
| SPECTRUM BRANDS, INC. | – | Remington Luma Rx Remington Products | registered |
| Venus Concept USA, Inc. | United States | Venus Versa - SR580 light block package Venus Versa - SR515 light block package HR650 applicator HR690 applicator Venus Versa - HR650 light block package HR650XL applicator | K232192 (2023) |
| HOME SKINOVATIONS LTD | Israel | Silk'n Remington PHILIPS | registered |
| ILUMINAGE LTD | – | Me Iluminage | registered |
| Inmode MD , Ltd. | Israel | Lumecca Peak Plus Applicator Lumecca 515 Envision System Lumecca 580 OptimasMax platform | K123860 (2013) |
| Silkn Beauty Ltd. Present in Europe in other categories | Netherlands | Silk'n | registered |
| VYDENCE MEDICAL Present in Europe in other categories | Brazil | ZYE-ULTRA FDA IPL-Sq ETHEREA-MX ZYE YAG ONE FDA ZYE ALX | registered |
| BTL Industries, Inc. Present in Europe in other categories | United States | BTL Exilite handpiece BTL Exilite | K150051 (2015) |
| Ellipse A/S | Denmark | Ellipse Nordlys Ellipse Sirius Ellipse Nordlys USA Ellipse Sirius USA Nd:YAG MultiFlex | K140670 (2014) |
| Shenzhen Fansizhe Science And Technology Co., Ltd. | China | Intense Pulsed Light (IPL) System | registered |
| El.En S.P.A. Present in Europe in other categories | Italy | DEKA LUXEA DEKA Minisilk FT Thermaeye Plus DEKA TRUIST | K250281 (2025) |
| Theravant Corporation | United States | TheraClear | K123889 (2013) |
| Viora , Ltd. | Israel | Trios™ SR Hand piece AC Hand piece HR Hand piece | K090399 (2009) |
| Stetic Medical Aesthetics Development (Shenzhen)Co.,Ltd. | China | HOMEDICS STETIC SENSE | K161565 (2016) |
| Beijing Globalipl Development Co., Ltd. Present in Europe in other categories | China | Globalipl | K220385 (2022) |
| Beijing Kes Biology Technology Co., Ltd. Present in Europe in other categories | China | KES | K122995 (2013) |
| Dectro International | Canada | Apilux | registered |
| Sciton, Inc | United States | mJoule JOULE | registered |
| TENTECH Inc. | South Korea | 10PL | K220794 (2022) |
| BIOTEC ITALIA SRL Present in Europe in other categories | Italy | XLase Plus | registered |
| Beijing Adss Development Co., Ltd. Present in Europe in other categories | China | Ipl Therapy Machine | K233307 (2024) |
| Beijing Honkon Technologies Co., Ltd. Present in Europe in other categories | China | MULTIFUNCTIONAL SERIES | K131859 (2013) |
| Beijing Superlaser Technology Co., Ltd. | China | SUPERLASER | K192519 (2019) |
| Candela Corp. Present in Europe in other categories | United States | Nordlys System | registered |
| E-SWIN Present in Europe in other categories | France | E>EYE C | K200616 (2020) |
| EL GLOBAL TRADE LTD | Israel | Sensilight Pro - bronze | registered |
| Hebei Zhemai Technology Co., Ltd. | China | ZHEONE | K232708 (2023) |
| Hunan Guangye Biotechnology Co., Ltd. | – | Nood | registered |
| Inbella Medical Inc | Canada | InBellaMax System | registered |
| Jeisys Medical, Inc. Present in Europe in other categories | South Korea | SmoothCool | K092326 (2010) |
| Luvo Medical Technologies, Inc. Present in Europe in other categories | Canada | Lucent IPL | K193072 (2020) |
| MDElite Laser and Aesthetic, LLC | – | MDElite iProX | registered |
| MEDICREATIONS LLC | United States | MediLight | K231952 (2025) |
| Micowey Medical Equipment (Guangxi) Co., LTD | China | MICOWEY | K251545 (2025) |
| Nanjing Bestview Laser S&T Co., Ltd. | China | BVLASER | K242440 (2024) |
| Quanta System Spa Present in Europe in other categories | Italy | Twain 2940 | registered |
| Shanghai Bele Medical Technology Co., Ltd. | China | Bilens | registered |
| Shenzhen Boyuan Intelligent Electronic Technology Co., Ltd | China | Nood | K210119 (2021) |
| T AESTHETICS LLC | – | NextGen Aesthetics IPL | registered |
| ATENA (FROM THE IMCO GROUP) LTD | Israel | – | registered |
| Aesthetic ProTools, Inc. | United States | – | registered |
| Amt Engineering Co., Ltd. | South Korea | – | registered |
| B.Y. Medimor Ltd | Israel | – | registered |
| Beijing Beautemax Technology Limited | China | – | registered |
| Beijing Mingqiao Technology Co. , Ltd. | China | – | registered |
| Beijing Sincoheren Science and TechnologyDevelopment Co., Lt | China | – | registered |
| Beijing Starlight Science & Technology Development | China | – | K101901 (2011) |
| Beijing Winkonlaser Technology Limited | China | – | registered |
| Cyden Limited | United Kingdom | – | registered |
| Dezhou Globalipl Medical Technology Co., Ltd. | China | – | registered |
| El.En Electronic Engineering Spa | Italy | – | K082040 (2009) |
| Guangzhou Ciellulu Photoelectric Technology Co., Ltd. | China | – | K240314 (2024) |
| Guangzhou Enzoeys photoelectric Technology Co,Ltd. | China | – | registered |
| Guangzhou Telefield Limited | China | – | registered |
| HEBEI MITA BIOTECHNOLOGY LIMITED | Hong Kong SAR China | – | registered |
| HEBEI MITA TECHNOLOGY LIMITED | Hong Kong SAR China | – | registered |
| InMode , Ltd. Present in Europe in other categories | Israel | – | registered |
| Jabil Inc. | United States | – | registered |
| Kam Yuen Plastic Products , Ltd. | China | – | K212907 (2021) |
| Medusa (Guangxi)Medical Devices Co., Ltd. | China | – | K243123 (2025) |
| Miley Technology (Hebei) Co., LTD | China | – | registered |
| Procter & Gamble | United States | – | registered |
| R. H. Electronics Ltd. | Israel | – | registered |
| Rejuva Fresh LLC | China | – | registered |
| SILKN CANADA CORP. Present in Europe in other categories | Canada | – | registered |
| Sanhe Lefis Electronics Co., Ltd. | China | – | K261204 (2026) |
| Shangdong Huamei Technology Co., Ltd. | China | – | K230816 (2023) |
| Shanghai Omni Laser Skinology Co., Ltd. | China | – | K220214 (2023) |
| Sharplight Technologies, Ltd. | Israel | – | registered |
| Shenzhen Accompany Technology Co., Ltd. | China | – | K212099 (2021) |
| Shenzhen Ionka Medical Technology Co., Ltd. | China | – | K221214 (2022) |
| Shenzhen Mywin Technology Co., Ltd. | China | – | K211368 (2021) |
| Shenzhen Perfect Idea Technology Limited | China | – | registered |
| Shenzhen Zhao Heng Xing Electronic Co., Ltd. | China | – | registered |
| Smedtrum Medical Technology Co., Ltd. | Taiwan | – | K240482 (2024) |
| Strata Skin Sciences, Inc. | United States | – | registered |
| TOUCHBEAUTY BEAUTY & HEALTH (SHENZHEN) CO., LTD | China | – | registered |
| Ulike Co., Ltd. | South Korea | – | K213558 (2022) |
| VTech Communications Ltd | China | – | registered |
| Vydence Medical Industria E Comercio Ltda Present in Europe in other categories | Brazil | – | registered |
| WORLD AESTHETIX LLC | United States | – | registered |
| XIAMEN SOLEX HIGH-TECH INDUSTRIES CO.,LTD | China | – | registered |
| guangdong fuqiang beauty equipment co.,Limited | China | – | registered |
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