510(k) submissions
All indexed GEX clearances · showing 51–100 of 667
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| K252319 | Q-Switched Nd: YAG Laser machine (LFS-C13U)Pigment treatment | Sanhe Lefis Electronics Co., Ltd.China | Nd:YAG | Class 2 | 2025-10-20 |
| K250776 | Lithoblast Single Use Holmium Laser FibersSurgical cutting | Dawell Medical, LLCUnited States | Er:YAG | Class 2 | 2025-10-14 |
| K251699 | The Botticelli (Model: Athena)Skin resurfacing | Bellamia Technologies, Inc.United States | Diode | Class 2 | 2025-10-08 |
| K251464 | TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Surgical cutting | Jeisys Medical IncorporatedKorea, Republic of | Nd:YAG | Class 2 | 2025-10-03 |
| K242946 | HESTIA (L200-A)Surgical cutting | Senbitec Co., Ltd.Korea, Republic of | CO2 | Class 2 | 2025-10-03 |
| K252447 | Picosecond laser device (BMPS4)Pigment treatment | Hebei Newangie Technology Co., Ltd.China | Picosecond | Class 2 | 2025-10-01 |
| K251919 | Thulium Laser System (Deluxlase)Pigment treatment | Nanjing Bestview Laser S&T Co., Ltd.China | Thulium fiber | Class 2 | 2025-09-26 |
| K252063 | Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N); Medical Diode Laser Systems (HARLAS-45JN); Medical Diode Laser Systems (HARLAS-46JN)Vascular treatment | Wuhan Dimed Laser Technology Co., Ltd.China | Diode | Class 2 | 2025-09-25 |
| K250071 | Alma FemiLift Pixel CO2 Laser System, Delivery Devices and AccessoriesSurgical cutting | Alma Lasers, Inc.United States | CO2 | Class 2 | 2025-09-24 |
| K251100 | IPGTFL-02Other | Ipg Medical CorporationUnited States | Thulium fiber | Class 2 | 2025-09-19 |
| K242859 | VEGAHair removal | Ibramed Equipamentos MédicosBrazil | Diode | Class 2 | 2025-09-19 |
| K251457 | Diode laser therapy device (VADER)Hair removal | Beijing Superlaser Technology Co., Ltd.China | Diode | Class 2 | 2025-09-03 |
| K251727 | GLAM LED Facial Mask (TB-2386F)Acne treatment | Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.China | LED | Class 2 | 2025-08-29 |
| K250261 | Heager Medical Laser Family (Sabrina/Adolf)Surgical cutting | Heager GmbHUnited States | Diode | Class 2 | 2025-08-26 |
| K251801 | Diode laser device (BM091)Hair removal | Hebei Newangie Technology Co., Ltd.China | Diode | Class 2 | 2025-08-08 |
| K251432 | OloVascular treatment | El.En S.P.A.Italy | Nd:YAG | Class 2 | 2025-08-06 |
| K251076 | Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)Hair removal | Shenzhen Lifotronic Technology Co., Ltd.China | Diode | Class 2 | 2025-07-30 |
| K251339 | Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04)Hair removal | Zhengzhou PZ Laser Slim Technology Co., Ltd.China | Diode | Class 2 | 2025-07-25 |
| K250504 | Leonardo DusterSurgical cutting | Ceramoptec GmbHUnited States | Other | Class 2 | 2025-07-14 |
| K251149 | AviClear Laser SystemAcne treatment | Cutera, Inc.United States | Other | Class 2 | 2025-07-11 |
| K251759 | Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser FibersSurgical cutting | Boston Scientific CorporationUnited States | Laser fiber / delivery | Class 2 | 2025-07-09 |
| K250165 | PastelleSurgical cutting | Wontech Co., Ltd.Korea, Republic of | Nd:YAG | Class 2 | 2025-07-03 |
| K251049 | SurgiLight 1470 Diode Laser System (Model:Halo)Surgical cutting | Micro-Energy Medical Technology Co., Ltd.China | Diode | Class 2 | 2025-07-02 |
| K243701 | AuroLase® SystemSurgical cutting | Nanospectra Biosciences, Inc.United States | Diode | Class 2 | 2025-07-02 |
| K251329 | Diode laser device (RF3120-BI)Hair removal | Risu Medical Technology Co., Ltd.China | Diode | Class 2 | 2025-06-27 |
| K251632 | Optimas MAX SystemHair removal | InMode , Ltd.France | Diode | Class 2 | 2025-06-26 |
| K250936 | Q-Switched Nd:YAG Laser (SHE-LSP101-1)Pigment treatment | Beijing Sano Laser S&T Development Co.,LtdChina | Nd:YAG | Class 2 | 2025-06-12 |
| K250782 | Fractional CO2 Laser MachineSkin resurfacing | Zhengzhou PZ Laser Slim Technology Co., Ltd.China | CO2 | Class 2 | 2025-06-12 |
| K243683 | Deka BluebeamSurgical cutting | El.En S.P.A.Italy | Diode | Class 2 | 2025-06-12 |
| K250465 | CO2 Laser Machine (Lume)Surgical cutting | Nanjing Bestview Laser S&T Co., Ltd.China | CO2 | Class 2 | 2025-06-09 |
| K250722 | Nd: YAG Laser Therapy System (QN-1)Pigment treatment | Hebei JT Medical Co., Ltd.China | Nd:YAG | Class 2 | 2025-06-06 |
| K240983 | Discovery Pico; Discovery Pico Plus; Discovery Pico DermPigment treatment | Quanta System SpaItaly | Q-Switched | Class 2 | 2025-06-06 |
| K250195 | MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60)Vascular treatment | Matelaser, Inc.United States | Other | Class 2 | 2025-05-30 |
| K251230 | The Alma Hybrid Laser SystemSurgical cutting | Alma Lasers, Inc.United States | CO2 | Class 2 | 2025-05-21 |
| K251288 | VeincareVascular treatment | Wontech Co., Ltd.Korea, Republic of | Diode | Class 2 | 2025-05-14 |
| K250041 | Medical Picosecond ND: YAG Laser System (PZ-6)Pigment treatment | Zhengzhou PZ Laser Slim Technology Co., Ltd.China | Picosecond | Class 2 | 2025-05-14 |
| K250431 | Medical Diode Laser Hair Removal System (MNLT-D1)Hair removal | Shandong Moonlight Electronics Tech Co., Ltd.China | Diode | Class 2 | 2025-05-12 |
| K251094 | Alma VeilVascular treatment | Wontech Co., Ltd.Korea, Republic of | Nd:YAG | Class 2 | 2025-05-06 |
| K242951 | Diode laser hair removal machine (QDTM-02)Hair removal | Beijing Nubway S&T Co., Ltd.China | Diode | Class 2 | 2025-04-28 |
| K250206 | Diode laser system (Night Universe; Predator)Hair removal | Ivylaser (Beijing) Technology Co.,LtdChina | Diode | Class 2 | 2025-04-24 |
| K250183 | CO2 Laser System (CO2 Laser SST-L23)Surgical cutting | Zhuozhou Summer Star Technologies Co., Ltd.China | CO2 | Class 2 | 2025-04-24 |
| K250809 | Stellar M22Hair removal | Lumenis Be, Ltd.Israel | Nd:YAG | Class 2 | 2025-04-16 |
| K243044 | Alma HarmonyHair removal | Alma Lasers, Inc.United States | Nd:YAG | Class 2 | 2025-04-11 |
| K250656 | Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Surgical cutting | Wuhan Pioon Technology Co., Ltd.China | Diode | Class 2 | 2025-04-04 |
| K250189 | AdvaTxVascular treatment | Advalight ApsDenmark | Nd:YAG | Class 2 | 2025-04-01 |
| K250018 | Medical Diode Laser Systems (THEIA808)Hair removal | Gigaalaser Company , Ltd.China | Diode | Class 2 | 2025-04-01 |
| K243630 | Medical Laser System Incanto / Evoline Platinum /EvolineHair removal | Solar LS CjscBelarus | Alexandrite | Class 2 | 2025-03-21 |
| K241791 | Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D)Surgical cutting | Gigaalaser Company , Ltd.China | Diode | Class 2 | 2025-03-19 |
| K250113 | neoLaser Laser Surgery FibersSurgical cutting | G.N.S Neolaser , Ltd.Israel | Laser fiber / delivery | Class 2 | 2025-03-13 |
| K243993 | Photon Therapy Apparatus (BL-10)Pigment treatment | Xemis Medical Technology (Shenzhen) Co., Ltd.China | LED | Class 2 | 2025-03-13 |