510(k) submissions
Filtered by Vascular treatment · showing 1–50 of 220
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| K260256 | Q-Switched Nd: YAG Laser SystemsPigment treatment | Shanghai Apolo Medical Technology Co., Ltd.China | Q-Switched | Class 2 | 2026-05-04 |
| K261094 | YellowStarVascular treatment | Asclepion Laser Technologies GmbHUnited States | Diode | Class 2 | 2026-04-29 |
| K253765 | VANISH PROPigment treatment | Ddc Technologies, Inc.United States | Nd:YAG | Class 2 | 2026-04-22 |
| K260153 | Q-Switched Nd: YAG Laser System (Glamor Q)Pigment treatment | Nanjing Bestview Laser S&T Co., Ltd.China | Q-Switched | Class 2 | 2026-04-20 |
| K260017 | Picosecond Nd:YAG Laser Systems (Model: HS-298)Pigment treatment | Shanghai Apolo Medical Technology Co., Ltd.China | Nd:YAG | Class 2 | 2026-04-09 |
| K260375 | Nd: YAG Laser Therapy SystemsPigment treatment | Sanhe Meditech Co., Ltd.China | Nd:YAG | Class 2 | 2026-03-31 |
| K260632 | LASER THERMAL THERAPY KITSurgical cutting | Elesta S.P.AItaly | Nd:YAG | Class 2 | 2026-03-17 |
| K252971 | Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories)Surgical cutting | C.R. Bard, Inc.United States | Thulium fiber | Class 2 | 2026-03-17 |
| K253951 | Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B); Holmium Laser Therapeutic Apparatus (HZ-E)Surgical cutting | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.China | Nd:YAG | Class 2 | 2026-03-06 |
| K252599 | Diode Laser Therapy Systems (WLA-02)Hair removal | Wingderm Electro-Optics , Ltd.China | Diode | Class 2 | 2026-02-24 |
| K253633 | Holmium Laser Therapeutic Apparatus (HZ-40)Surgical cutting | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.China | Nd:YAG | Class 2 | 2026-01-24 |
| K252753 | Vydence Family of LasersHair removal | Vydence Medical Industria E Commercio LtdaBrazil | Nd:YAG | Class 2 | 2026-01-24 |
| K251077 | JOULE 1064nm System and AccessoriesVascular treatment | Sciton, IncUnited States | Nd:YAG | Class 2 | 2025-12-19 |
| K252745 | Halo Sterile Single-use Radial Fiber (Halo-R-0.40-2.5/Halo-R-0.60-2.5/Novo-R-0.60-1.8/Novo-R-0.40-1.8)Surgical cutting | Micro-Energy Medical Technology Co., Ltd.China | Diode | Class 2 | 2025-12-12 |
| K253219 | LeafPure-Echo (LM-LPNdA)Pigment treatment | Shenzhen Leaflife Technology Co., Ltd.China | Nd:YAG | Class 2 | 2025-11-25 |
| K252787 | Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B)Surgical cutting | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.China | Thulium fiber | Class 2 | 2025-11-24 |
| K253123 | CuRAS hybridSurgical cutting | Classys, Inc.Korea, Republic of | Nd:YAG | Class 2 | 2025-11-20 |
| K252564 | Medical Diode Laser Systems (VeinCure)Vascular treatment | Baoding Te'Anzhou Electronic Technology Co., Ltd.China | Diode | Class 2 | 2025-11-07 |
| K251824 | Patriot DuoSurgical cutting | Patriot Laser, LLCUnited States | Laser fiber / delivery | Class 2 | 2025-10-27 |
| K253100 | MultiPulse TFLSurgical cutting | Asclepion Laser Technologies GmbHUnited States | Thulium fiber | Class 2 | 2025-10-23 |
| K252732 | 1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)Pigment treatment | Zhengzhou PZ Laser Slim Technology Co., Ltd.China | Thulium fiber | Class 2 | 2025-10-23 |
| K252319 | Q-Switched Nd: YAG Laser machine (LFS-C13U)Pigment treatment | Sanhe Lefis Electronics Co., Ltd.China | Nd:YAG | Class 2 | 2025-10-20 |
| K251699 | The Botticelli (Model: Athena)Skin resurfacing | Bellamia Technologies, Inc.United States | Diode | Class 2 | 2025-10-08 |
| 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 |
| K250261 | Heager Medical Laser Family (Sabrina/Adolf)Surgical cutting | Heager GmbHUnited States | Diode | Class 2 | 2025-08-26 |
| K251432 | OloVascular treatment | El.En S.P.A.Italy | Nd:YAG | Class 2 | 2025-08-06 |
| 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 |
| 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 |
| 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 |
| 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 |
| K251094 | Alma VeilVascular treatment | Wontech Co., Ltd.Korea, Republic of | Nd:YAG | Class 2 | 2025-05-06 |
| K250809 | Stellar M22Hair removal | Lumenis Be, Ltd.Israel | Nd:YAG | Class 2 | 2025-04-16 |
| K250189 | AdvaTxVascular treatment | Advalight ApsDenmark | Nd:YAG | Class 2 | 2025-04-01 |
| K250113 | neoLaser Laser Surgery FibersSurgical cutting | G.N.S Neolaser , Ltd.Israel | Laser fiber / delivery | Class 2 | 2025-03-13 |
| K242943 | Q Switched Nd:YAG Laser machine (QNHF-01)Pigment treatment | Beijing Nubway S&T Co., Ltd.China | Nd:YAG | Class 2 | 2025-03-03 |
| K243780 | HELIOS 785 Pico (1754V2)Pigment treatment | Laseroptek Co., Ltd.Korea, Republic of | Q-Switched | Class 2 | 2025-02-07 |
| K241270 | BTL-754Skin resurfacing | BTL Industries, Inc.United States | Er:YAG | Class 2 | 2025-01-30 |
| K243445 | Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Hair removal | Bios S.R.L.Italy | Nd:YAG | Class 2 | 2024-12-30 |
| K243121 | SLT Select Fiber Delivery System and Contact Tips (models: SSRH 8-SMA; TCRH 7-SMA; FEF 2.2-SMA; CFE 0.6-SMA; SSRH 8Z-SMA; SSRH 4-SMA; SSRH 6-SMA; SSRH 9-SMA; SSRH 10-SMA; SSRH 11-SMA; SSRH 7L-SMA; TCRH 7Z-SMA; FEF 1.8-SMA; CFE 0.55-SMA; CFE 0.36-SMA; LAL 550-SMA; LAL 550Z-SMA; LAL 365-SMA; LAL 365Z-SMA; ER2; ERP2; GR2; GRP2; ER4; ERP4; GR4; GRP4; ER6; ERP6; GR6; GRP6; ER8; ERP8; GR8; GRP8; ER10; ERP10; GR10; GRP10; ER12; ERP12; GR12; GRP12; MD2.5; MD3.5; HP1.0; MTP1.5; MTP3.5; MTRG1.5;Surgical cutting | Jiangxi Medex Technology Co., Ltd.China | Diode | Class 2 | 2024-12-22 |
| K242987 | Thulium Fiber Laser (FiberLAZE+, FiberLAZE)Surgical cutting | Allengers Global Healthcare Private LimitedIndia | Thulium fiber | Class 2 | 2024-12-17 |
| K241930 | VeincareVascular treatment | Wontech Co., Ltd.Korea, Republic of | Diode | Class 2 | 2024-11-14 |
| K240543 | Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia)Surgical cutting | Medency S.R.L.Italy | Diode | Class 2 | 2024-10-24 |
| K241951 | Lasya-TrinityHair removal | BLUECORE COMPANY Co., Ltd.Korea, Republic of | Diode | Class 2 | 2024-10-10 |
