510(k) submissions
Filtered by Vascular treatment · showing 51–100 of 220
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| K242206 | ACTIVOSurgical cutting | Daeju Meditech Engineering Co., Ltd.Korea, Republic of | Nd:YAG | Class 2 | 2024-09-27 |
| 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 |
| K242251 | Litho 60; Litho 100; Litho 150Surgical cutting | Quanta System SpaItaly | Holmium (Ho:YAG) | Class 2 | 2024-09-03 |
| K242191 | SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)Surgical cutting | Olympus Surgical Technologies AmericaUnited States | Thulium fiber | Class 2 | 2024-08-23 |
| K241406 | LavieenPigment treatment | Wontech Co., Ltd.Korea, Republic of | Thulium fiber | Class 2 | 2024-06-28 |
| K241459 | MOTUS PRO FamilyHair removal | El.En S.P.A.Italy | Diode | Class 2 | 2024-06-21 |
| K241407 | Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Hair removal | Bios S.R.L.Italy | Nd:YAG | Class 2 | 2024-06-14 |
| K240222 | Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024)Acne treatment | Aesthetic Technology, Ltd.United Kingdom | LED | Class 2 | 2024-06-04 |
| K240159 | InnoVoyce VYLOSurgical cutting | InnovoyceUnited States | Diode | Class 2 | 2024-05-29 |
| K240474 | Multi-function Platform Systems (BL-M10)Hair removal | Shanghai Bele Medical Technology Co.,LtdChina | Nd:YAG | Class 2 | 2024-05-20 |
| K240752 | DEKA TOROPigment treatment | El.En S.P.A.Italy | Q-Switched | Class 2 | 2024-05-16 |
| K233803 | UltraClear Laser System (N/A)Skin resurfacing | Acclaro CorporationUnited States | CO2 | Class 2 | 2024-05-08 |
| K240118 | Picosecond Nd:YAG Laser SystemPigment treatment | Smedtrum Medical Technology Co., Ltd.Taiwan | Nd:YAG | Class 2 | 2024-04-30 |
| K240816 | MeDioStarHair removal | Asclepion Laser Technologies GmbHUnited States | Diode | Class 2 | 2024-04-23 |
| K240179 | Medical Diode Laser (Model: L2)Surgical cutting | Wuhan Pioon Technology Co., Ltd.China | Diode | Class 2 | 2024-03-21 |
| K232568 | IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and AccessoriesSurgical cutting | Ipg Medical CorporationUnited States | Thulium fiber | Class 2 | 2024-03-21 |
| K240396 | Elite iQ PRO (M122K1)Hair removal | Cynosure, LLCUnited States | Alexandrite | Class 2 | 2024-03-08 |
| K231876 | MultiPulse HoPLUSSurgical cutting | Asclepion Laser Technologies GmbHUnited States | Holmium (Ho:YAG) | Class 2 | 2024-02-22 |
| K231896 | Diode Laser Therapy SystemHair removal | Beijing Adss Development Co., Ltd.China | Diode | Class 2 | 2024-02-20 |
| K231910 | DermRays ReviveHair removal | Wuhan Lotuxs Technology Co., Ltd.China | Diode | Class 2 | 2024-01-30 |
| K233077 | FlashHeal 2 (FlashHeal 2.0)Acne treatment | Inwound ApsDenmark | LED | Class 2 | 2024-01-18 |
| K233304 | Omnimax S3, Omnimax S4Hair removal | Sharplight Technologies, Ltd.Israel | IPL | Class 2 | 2023-12-22 |
| K232769 | BeaMed Laser Surgery FibersSurgical cutting | Bt Beamedical Tachnoogies Ltd. (Beamed)Israel | Laser fiber / delivery | Class 2 | 2023-12-06 |
| K232716 | Q-Switched Nd:Yag laserPigment treatment | Hebei Zhemai Technology Co., Ltd.China | Nd:YAG | Class 2 | 2023-11-30 |
| K232117 | Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)Hair removal | Wuhan Lotuxs Technology Co., Ltd.China | Diode | Class 2 | 2023-11-28 |
| K232532 | Nd:Yag Laser Therapy SystemsSurgical cutting | Beijing Unt Technology Co., Ltd.China | Nd:YAG | Class 2 | 2023-11-02 |
| K232236 | EchoHair removal | Quanta System SpaItaly | Diode | Class 2 | 2023-10-20 |
| K223727 | LavieenPigment treatment | Wontech Co., Ltd.Korea, Republic of | CO2 | Class 2 | 2023-08-25 |
| K231718 | Holmium Medical LaserSurgical cutting | Allengers Global Healthcare Private LimitedIndia | Holmium (Ho:YAG) | Class 2 | 2023-08-18 |
| K230342 | Phototherapy System (OL-PDT950)Acne treatment | Shanghai Omni Laser Skinology Co., Ltd.China | LED | Class 2 | 2023-08-16 |
| K231054 | V-LaserVascular treatment | Wontech Co., Ltd.Korea, Republic of | Nd:YAG | Class 2 | 2023-08-14 |
| K231548 | Medical Diode Laser, Model S1ProVascular treatment | Wuhan Pioon Technology Co., Ltd.China | Diode | Class 2 | 2023-08-03 |
| K231945 | VenaCure EVLT NeverTouch Procedure Kits; VenaCure EVLT NeverTouch Direct Procedure KitsVascular treatment | AngioDynamics, Inc.United States | Laser fiber / delivery | Class 2 | 2023-07-20 |
| K230077 | LaserMESkin resurfacing | Neauvia North AmericaUnited States | CO2 | Class 2 | 2023-07-17 |
| K230990 | Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)Vascular treatment | Candela CorporationUnited States | Other | Class 2 | 2023-06-01 |
| K230460 | Laser Thermal Therapy KitSurgical cutting | Elesta S.P.AItaly | Nd:YAG | Class 2 | 2023-05-22 |
| K230373 | HELIOS 785 PicoSurgical cutting | Laseroptek Co., Ltd.Korea, Republic of | Q-Switched | Class 2 | 2023-05-22 |
| K230340 | Lucas PlusSurgical cutting | Amt Engineering Co., Ltd.Korea, Republic of | Nd:YAG | Class 2 | 2023-05-04 |
| K230308 | Alma HarmonyHair removal | Alma Lasers, Inc.United States | IPL | Class 2 | 2023-03-01 |
| K230371 | The Alma Soprano TitaniumHair removal | Alma Lasers, Inc.United States | Diode | Class 2 | 2023-02-22 |
| K222751 | LED Light Therapy Device, KN-7000LAcne treatment | Xuzhou Kernel Medical Equipment Co., Ltd.China | LED | Class 2 | 2023-02-01 |
| K221306 | SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and AccessoriesSurgical cutting | Gyrus Acmi, Inc.United States | Thulium fiber | Class 2 | 2023-01-27 |
| K223404 | Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VVascular treatment | Quanta System SpaItaly | Nd:YAG | Class 2 | 2023-01-20 |
| K222915 | Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE PLUSVascular treatment | Canadian Pioneer Medical Technology Corporation (Cpmt Laser)Canada | Nd:YAG | Class 2 | 2022-11-15 |
| K222064 | The Alma Soprano TitaniumHair removal | Alma Lasers, Inc.United States | Diode | Class 2 | 2022-10-12 |
| K222369 | PURE LaserHair removal | Endymed Medical, Ltd.Israel | Diode | Class 2 | 2022-10-07 |
| K222555 | reepot Nd; YAG laser systemSurgical cutting | Ilooda Co,., Ltd.Korea, Republic of | Nd:YAG | Class 2 | 2022-09-23 |
| K212790 | XLase PlusHair removal | Biotec Italia, SrlItaly | Diode | Class 2 | 2022-08-15 |
| K221789 | IRIS Pi Q switched Nd YAG laserSurgical cutting | Bio-Med USA, Inc.United States | Nd:YAG | Class 2 | 2022-08-09 |
