510(k) submissions
Filtered by Diode · showing 1–50 of 192
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| K253251 | Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece: Quad (810-b and Blend-b)Hair removal | Leaseir Technologies, SluSpain | Diode | Class 2 | 2026-05-04 |
| K261094 | YellowStarVascular treatment | Asclepion Laser Technologies GmbHUnited States | Diode | Class 2 | 2026-04-29 |
| K260307 | Diode Laser Therapy Systems (V19)Hair removal | Weifang Mingliang Electronics Co., Ltd.China | Diode | Class 2 | 2026-04-15 |
| K254197 | Picasso Pro Diode Laser (002-00460)Surgical cutting | CAO Group, Inc.United States | Diode | Class 2 | 2026-03-11 |
| K254271 | CAPRISurgical cutting | ORO Co., Ltd.Korea, Republic of | Diode | Class 2 | 2026-02-26 |
| K252599 | Diode Laser Therapy Systems (WLA-02)Hair removal | Wingderm Electro-Optics , Ltd.China | Diode | Class 2 | 2026-02-24 |
| K252048 | 808nm semiconductor laser hair removal machineHair removal | Xi'An Taibo Electronic Technology Co., Ltd.China | Diode | Class 2 | 2026-02-03 |
| 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 |
| K252658 | Medical Diode Laser Systems (TR-B)Surgical cutting | Baoding Te'Anzhou Electronic Technology Co., Ltd.China | Diode | Class 2 | 2025-11-28 |
| K252564 | Medical Diode Laser Systems (VeinCure)Vascular treatment | Baoding Te'Anzhou Electronic Technology Co., Ltd.China | Diode | Class 2 | 2025-11-07 |
| K252427 | Diode Laser Hair Removal Machine (GLD01)Hair removal | Sanhe Meditech Co., Ltd.China | Diode | Class 2 | 2025-10-31 |
| K251699 | The Botticelli (Model: Athena)Skin resurfacing | Bellamia Technologies, Inc.United States | Diode | Class 2 | 2025-10-08 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| K243683 | Deka BluebeamSurgical cutting | El.En S.P.A.Italy | Diode | Class 2 | 2025-06-12 |
| K251288 | VeincareVascular treatment | Wontech Co., Ltd.Korea, Republic of | Diode | 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 |
| 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 |
| 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 |
| K250018 | Medical Diode Laser Systems (THEIA808)Hair removal | Gigaalaser Company , Ltd.China | Diode | Class 2 | 2025-04-01 |
| 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 |
| K242207 | NOABLE LASERSurgical cutting | Daeju Meditech Engineering Co., Ltd.Korea, Republic of | Diode | Class 2 | 2025-03-07 |
| K234004 | Medical diode laser systems (CHARISMA, REGAL)Skin resurfacing | Reveal Lasers , Ltd.United States | Diode | Class 2 | 2025-02-20 |
| K243465 | Diode Laser Hair Removal Device (EVOLUTION MEDICAL); Diode Laser Hair Removal Device (M-I-X MEDICAL); Diode Laser Hair Removal Device (GENESIS); Diode Laser Hair Removal Device (Lotus); Diode Laser Hair Removal Device (Ultimate)Hair removal | Guangzhou Chuang Zao Mei Technology Co., Ltd.China | Diode | Class 2 | 2025-02-06 |
| K243141 | Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser System (Aurolance 980); Diode Laser System (Aurolance 810); Diode Laser System (Aurolance AM)Surgical cutting | Jiangxi Medex Technology Co., Ltd.China | Diode | Class 2 | 2024-12-26 |
| K243037 | Diode Laser System model Dawn-SSurgical cutting | Shanghai Wonderful Opto-Electrics Tech.Co.,LtdChina | Diode | Class 2 | 2024-12-26 |
| 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 |
| K241498 | Diode laser Treatment System (K18)Hair removal | Hebei Keylaser Sci-Tech Co.,LtdChina | Diode | Class 2 | 2024-11-18 |
| 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 |
| K241860 | Diode Laser Hair Removal SystemHair removal | Beijing Winkonlaser Technology LimitedChina | Diode | Class 2 | 2024-09-25 |
| K240604 | MTONE EVO (MTONE EVO)Vascular treatment | M&T S.R.L.Italy | Diode | Class 2 | 2024-09-20 |
| K241771 | Liftendo; Liftendo 2.0Surgical cutting | Medical San Indústria DE Equipamentos Médicos Ltda.Brazil | Diode | Class 2 | 2024-09-16 |
| K241547 | Diode Laser Therapy Device (DF-DIODE LASER-S1)Hair removal | Weifang Dragonfly Electronics Technology Co., Ltd.China | Diode | Class 2 | 2024-08-13 |
| K231950 | MEDIDIODEHair removal | Medicreations, LLCUnited States | Diode | Class 2 | 2024-08-09 |
| K241642 | Diode Laser Hair Removal System (MBT-Diode Laser)Hair removal | Beijing Mega Beauty Technology Co., Ltd.China | Diode | Class 2 | 2024-08-02 |
| K241459 | MOTUS PRO FamilyHair removal | El.En S.P.A.Italy | Diode | Class 2 | 2024-06-21 |
| K240611 | IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Hair removal | Ivylaser (Beijing) Technology Co.,LtdChina | Diode | Class 2 | 2024-06-20 |
| K240747 | Medical Diode Laser (M2-GK)Surgical cutting | Wuhan Pioon Technology Co., Ltd.China | Diode | Class 2 | 2024-06-17 |