510(k) submissions
Filtered by Surgical cutting · showing 51–100 of 340
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| K242207 | NOABLE LASERSurgical cutting | Daeju Meditech Engineering Co., Ltd.Korea, Republic of | Diode | Class 2 | 2025-03-07 |
| 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 |
| K234004 | Medical diode laser systems (CHARISMA, REGAL)Skin resurfacing | Reveal Lasers , Ltd.United States | Diode | Class 2 | 2025-02-20 |
| K243588 | Single Use CO2 Laser Fiber (HAF005001)Surgical cutting | Quanta System SpaItaly | CO2 | Class 2 | 2025-02-19 |
| K241643 | WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Surgical cutting | Wontech Co., Ltd.Korea, Republic of | Laser fiber / delivery | Class 2 | 2025-02-14 |
| K241527 | Pastelle ProPigment treatment | Wontech Co., Ltd.Korea, Republic of | Nd:YAG | Class 2 | 2025-02-14 |
| K242941 | CO2 Laser Therapy Systems (SHE-LSP003-1)Surgical cutting | Beijing Sano Laser S&T Development Co.,LtdChina | CO2 | Class 2 | 2025-01-27 |
| 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 |
| K243147 | LGO-Surgical Laser FibersSurgical cutting | Light Guide Optics International , Ltd.Latvia | Laser fiber / delivery | Class 2 | 2024-12-21 |
| K241670 | Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2)Surgical cutting | Beijing Adss Development Co., Ltd.China | CO2 | Class 2 | 2024-12-20 |
| K242987 | Thulium Fiber Laser (FiberLAZE+, FiberLAZE)Surgical cutting | Allengers Global Healthcare Private LimitedIndia | Thulium fiber | Class 2 | 2024-12-17 |
| K242293 | Medical Thulium Fiber Laser Systems (UroFiber 60Q)Surgical cutting | Rhein Laser Technologies Co., Ltd.China | Thulium fiber | Class 2 | 2024-11-19 |
| K241646 | ORTIV (ORTIV-BL, ORTIV-WH)Surgical cutting | Mvitro Co., Ltd.Korea, Republic of | Er:YAG | Class 2 | 2024-11-01 |
| 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 |
| K242183 | Fractional CO2 Laser Therapy System (EXFU CO2)Skin resurfacing | Weifang Mingliang Electronics Co., Ltd.China | CO2 | Class 2 | 2024-10-23 |
| K242132 | FREDDOSurgical cutting | Fabinject Lndustria E Comercio Lmportacao E Exportacao LtdaBrazil | Other | Class 2 | 2024-10-18 |
| K241092 | Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTSurgical cutting | Quanta System SpaItaly | CO2 | Class 2 | 2024-10-10 |
| K242206 | ACTIVOSurgical cutting | Daeju Meditech Engineering Co., Ltd.Korea, Republic of | Nd:YAG | Class 2 | 2024-09-27 |
| K241771 | Liftendo; Liftendo 2.0Surgical cutting | Medical San Indústria DE Equipamentos Médicos Ltda.Brazil | Diode | Class 2 | 2024-09-16 |
| K241672 | COPRO 3Surgical cutting | Amt Engineering Co., Ltd.Korea, Republic of | CO2 | Class 2 | 2024-09-06 |
| K242251 | Litho 60; Litho 100; Litho 150Surgical cutting | Quanta System SpaItaly | Holmium (Ho:YAG) | Class 2 | 2024-09-03 |
| K242202 | LightWalker Laser System FamilySurgical cutting | Fotona D.O.O.Slovenia | Er:YAG | Class 2 | 2024-08-23 |
| 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 |
| K241699 | SUPER VELOCESurgical cutting | Ilooda Co,., Ltd.Korea, Republic of | Other | Class 2 | 2024-08-13 |
| K241600 | DermablateSkin resurfacing | Asclepion Laser Technologies GmbHUnited States | CO2 | Class 2 | 2024-07-03 |
| K240747 | Medical Diode Laser (M2-GK)Surgical cutting | Wuhan Pioon Technology Co., Ltd.China | Diode | Class 2 | 2024-06-17 |
| K233007 | Picosecond Nd:YAG Laser System; PICO LEGENDPigment treatment | Ami, Inc.Korea, Republic of | Nd:YAG | Class 2 | 2024-06-12 |
| K240644 | Medical Diode Laser (S1Pro)Surgical cutting | Wuhan Pioon Technology Co., Ltd.China | Diode | Class 2 | 2024-06-10 |
| K240159 | InnoVoyce VYLOSurgical cutting | InnovoyceUnited States | Diode | Class 2 | 2024-05-29 |
| K233344 | Regenalase Laser SystemSurgical cutting | Ipg Medical CorporationUnited States | Diode | Class 2 | 2024-05-28 |
| K240752 | DEKA TOROPigment treatment | El.En S.P.A.Italy | Q-Switched | Class 2 | 2024-05-16 |
| K233157 | VaporMAX LDD; MOJo LDD; MegaJOULE LDDSurgical cutting | Innovaquartz, LLCUnited States | Laser fiber / delivery | Class 2 | 2024-05-03 |
| K232858 | ORskin BlueSurgical cutting | Megabay S.A.Argentina | Other | Class 2 | 2024-05-01 |
| K232133 | Co2 Laser System, Models: PureLase And VanLaseSurgical cutting | Cpmt Laser (Canadian Pioneer Medical Technology Corporation)Canada | CO2 | Class 2 | 2024-04-16 |
| 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 |
| K240537 | SMARTXIDE PROSkin resurfacing | El.En S.P.A.Italy | CO2 | Class 2 | 2024-03-20 |
| K240497 | Smartxide Tetra ProSkin resurfacing | El.En S.P.A.Italy | CO2 | Class 2 | 2024-03-12 |
| K231876 | MultiPulse HoPLUSSurgical cutting | Asclepion Laser Technologies GmbHUnited States | Holmium (Ho:YAG) | Class 2 | 2024-02-22 |
| K231514 | AzureSurgical cutting | Daeshin Enterprise Co., Ltd.Korea, Republic of | CO2 | Class 2 | 2024-02-14 |
| K233024 | Alma HarmonySkin resurfacing | Alma Lasers, Inc.United States | Er:YAG | Class 2 | 2024-02-08 |
| K233143 | PiXel8-RevealSkin resurfacing | Rohrer AestheticsUnited States | Er:YAG | Class 2 | 2024-02-02 |
| K232106 | Air Gap FiberSurgical cutting | Wontech Co., Ltd.Korea, Republic of | Laser fiber / delivery | Class 2 | 2024-01-08 |
| K221766 | SolonHair removal | Lmg Lasers Comercio, Importacao E Exportacao LtdaBrazil | Diode | Class 2 | 2024-01-05 |
| K233018 | PICOSECOND Nd:YAG Laser SystemPigment treatment | Ids, LimitedKorea, Republic of | Picosecond | Class 2 | 2023-12-21 |
| K231061 | NeuroBlate SystemSurgical cutting | Monteris Medical,United States | Nd:YAG | Class 2 | 2023-12-08 |
| K232769 | BeaMed Laser Surgery FibersSurgical cutting | Bt Beamedical Tachnoogies Ltd. (Beamed)Israel | Laser fiber / delivery | Class 2 | 2023-12-06 |
| K233301 | ULTRApulse Alpha CO2 Laser System, Delivery Devices and AccessoriesSurgical cutting | Lumenis Be, Ltd.Israel | CO2 | Class 2 | 2023-12-01 |
