510(k) submissions
Filtered by Surgical cutting · showing 101–150 of 340
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| K232532 | Nd:Yag Laser Therapy SystemsSurgical cutting | Beijing Unt Technology Co., Ltd.China | Nd:YAG | Class 2 | 2023-11-02 |
| K231791 | PENTO Nd:YAG and Alexandrite laser systemHair removal | Ilooda Co,., Ltd.Korea, Republic of | Nd:YAG | Class 2 | 2023-09-15 |
| K230535 | KARL STORZ Urological Laser AccessoriesSurgical cutting | Karl Storz SE & CO. KGUnited States | Laser fiber / delivery | Class 2 | 2023-09-08 |
| K231718 | Holmium Medical LaserSurgical cutting | Allengers Global Healthcare Private LimitedIndia | Holmium (Ho:YAG) | Class 2 | 2023-08-18 |
| K231054 | V-LaserVascular treatment | Wontech Co., Ltd.Korea, Republic of | Nd:YAG | Class 2 | 2023-08-14 |
| K230268 | ZenPro 40Surgical cutting | BLUECORE COMPANY Co., Ltd.Korea, Republic of | CO2 | Class 2 | 2023-08-10 |
| K212734 | Diode laser therapy deviceSurgical cutting | Triangel Rsd LimitedChina | Diode | Class 2 | 2023-06-06 |
| K212733 | Diode laser therapy deviceSurgical cutting | Beijing Star New Tech Co., Ltd.China | Diode | Class 2 | 2023-06-06 |
| K231309 | SCAR 3Skin resurfacing | El.En Electroinc Engineering SpaItaly | CO2 | Class 2 | 2023-06-02 |
| 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 |
| K230819 | OmniGuide RFID Surgical Laser FibersSurgical cutting | Omni-Guide Holdings, Inc.United States | Laser fiber / delivery | Class 2 | 2023-04-21 |
| K230274 | Medical Diode Laser (M2)Surgical cutting | Wuhan Pioon Technology Co., Ltd.China | Diode | Class 2 | 2023-03-31 |
| K222983 | NeuroBlate Fusion-S Software V3.17Surgical cutting | Monteris Medical,United States | Nd:YAG | Class 2 | 2023-03-15 |
| K213669 | LIGHTSCALPEL LS-4020Surgical cutting | Lightscalpel, Inc.United States | CO2 | Class 2 | 2023-02-15 |
| 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 |
| K222221 | DEKA HELIXSurgical cutting | El.En Electronic Engineering SpaItaly | CO2 | Class 2 | 2023-01-04 |
| K222701 | MANTA LaserSurgical cutting | Squalus Med , Ltd.Israel | Diode | Class 2 | 2022-11-18 |
| 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 |
| K221712 | Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Surgical cutting | Fotona D.O.O.Slovenia | Diode | Class 2 | 2022-10-12 |
| K222555 | reepot Nd; YAG laser systemSurgical cutting | Ilooda Co,., Ltd.Korea, Republic of | Nd:YAG | Class 2 | 2022-09-23 |
| K211605 | Dual SwitchSurgical cutting | Laser Engineering, Inc.United States | CO2 | Class 2 | 2022-09-22 |
| K221597 | CO2 Laser SystemSurgical cutting | Smedtrum Medical Technology Co., Ltd.Taiwan | CO2 | Class 2 | 2022-09-15 |
| K213267 | Dynamis Pro FamilySurgical cutting | Fotona D.O.O.Slovenia | Er:YAG | Class 2 | 2022-09-08 |
| K220531 | FOX 810, FOX 980Surgical cutting | A.R.C Laser GmbHUnited States | Diode | Class 2 | 2022-09-01 |
| K221427 | V-LaserSurgical cutting | Wontech Co., Ltd.Korea, Republic of | Nd:YAG | Class 2 | 2022-08-24 |
| K221789 | IRIS Pi Q switched Nd YAG laserSurgical cutting | Bio-Med USA, Inc.United States | Nd:YAG | Class 2 | 2022-08-09 |
| K213252 | Dornier ThulioSurgical cutting | Dornier Medtech America, Inc.United States | Thulium fiber | Class 2 | 2022-07-27 |
| K213761 | Joule diVa SystemVascular treatment | Sciton, IncUnited States | Diode | Class 2 | 2022-07-19 |
| K212073 | Alma Diode Tabletop LaserSurgical cutting | Alma Lasers, Inc.Israel | Diode | Class 2 | 2022-07-14 |
| K213250 | Secret DuoSkin resurfacing | Ilooda Co,., Ltd.Korea, Republic of | Other | Class 2 | 2022-06-24 |
| K212663 | HELIOS IV 785Surgical cutting | Laseroptek Co., Ltd.Korea, Republic of | Nd:YAG | Class 2 | 2022-06-09 |
| K220793 | InnoVoyce Laser FiberSurgical cutting | InnovoyceUnited States | Other | Class 2 | 2022-05-25 |
| K211534 | RevoLix HTLSurgical cutting | Lisa Laser Products GmbHUnited States | Other | Class 2 | 2022-05-19 |
| K220467 | The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and AccessoriesSurgical cutting | Lumenis Be, Ltd.Israel | CO2 | Class 2 | 2022-05-18 |
| K213594 | ECHOLASER X4Surgical cutting | Elesta S.P.AItaly | Other | Class 2 | 2022-05-03 |
| K220189 | LISA Laser Surgical FibersSurgical cutting | Omni-Guide Holdings, Inc.United States | Other | Class 2 | 2022-04-29 |
| K213350 | mJOULE System and AccessoriesVascular treatment | Sciton, IncUnited States | Nd:YAG | Class 2 | 2022-04-15 |
| K210634 | MCL 31 Dermablate SystemSkin resurfacing | Asclepion Laser Technologies GmbHUnited States | CO2 | Class 2 | 2022-04-13 |
| K213557 | FinexelSurgical cutting | SNJ Co., Ltd.Korea, Republic of | CO2 | Class 2 | 2022-04-12 |
| K220426 | Fiber Dust PROSurgical cutting | Quanta System SpaItaly | Other | Class 2 | 2022-03-16 |
| K213569 | HOLLYWOOD SPECTRA Laser SystemPigment treatment | Lutronic CorporationKorea, Republic of | Q-Switched | Class 2 | 2022-02-04 |
| K213554 | Sentient Manufacturing Laser FiberSurgical cutting | Sentient Manufacturing , LLCUnited States | Other | Class 2 | 2022-02-02 |
| K212611 | CO2 Laser EquipmentSurgical cutting | Beijing Globalipl Development Co., Ltd.China | CO2 | Class 2 | 2022-02-01 |
| K212127 | PicocaremajestyPigment treatment | Wontech Co., Ltd.Korea, Republic of | Picosecond | Class 2 | 2022-01-07 |
| K211517 | Optica XT Thulium Fiber Laser and Accessories, also known as Optica XT, Optica XT Thulium Fiber Laser, Thulium Fiber Laser 1940 nm, Optica XT Thulium Fiber Laser 1940 nm, Optica XT 60 Thulium Fiber Laser 1940 nm, Optica XT Superpulse Thulium Fiber Laser 1940 nm, OptiLITE Laser Fibers and AccessoriesSurgical cutting | Convergent Laser TechnologiesUnited States | Thulium fiber | Class 2 | 2021-11-09 |
| K211735 | CO2 Laser Machine, Model: BW-203BSurgical cutting | Zhengzhou Bestview ST Co., Ltd.China | CO2 | Class 2 | 2021-10-22 |
| K212270 | DEKA LipoAISurgical cutting | El.En Electronic Engineering SpaItaly | Nd:YAG | Class 2 | 2021-10-21 |