510(k) submissions
Filtered by CO2 · showing 1–50 of 79
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| K260974 | CO2 Laser Machine (Monica-I,Monica-II)Skin resurfacing | Nanjing Bestview Laser S&T Co., Ltd.China | CO2 | Class 2 | 2026-05-07 |
| K260257 | CO2 Laser SystemSurgical cutting | Sanhe Meditech Co., Ltd.China | CO2 | Class 2 | 2026-03-28 |
| K253920 | CO2 Laser Treatment Machine (CFR3M1)Surgical cutting | Haidari Beauty Technology (Beijing) Co., Ltd.China | CO2 | Class 2 | 2026-03-03 |
| K250998 | CO2 Laser Therapy System (Model: LFS-D9U)Skin resurfacing | Sanhe Lefis Electronics Co., Ltd.China | CO2 | Class 2 | 2025-12-19 |
| K252519 | CO2 Laser Therapy System (K106)Surgical cutting | Hebei Keylaser Sci-Tech Co.,LtdChina | CO2 | Class 2 | 2025-11-07 |
| K242946 | HESTIA (L200-A)Surgical cutting | Senbitec Co., Ltd.Korea, Republic of | CO2 | Class 2 | 2025-10-03 |
| K250071 | Alma FemiLift Pixel CO2 Laser System, Delivery Devices and AccessoriesSurgical cutting | Alma Lasers, Inc.United States | CO2 | Class 2 | 2025-09-24 |
| K250782 | Fractional CO2 Laser MachineSkin resurfacing | Zhengzhou PZ Laser Slim Technology Co., Ltd.China | CO2 | Class 2 | 2025-06-12 |
| K250465 | CO2 Laser Machine (Lume)Surgical cutting | Nanjing Bestview Laser S&T Co., Ltd.China | CO2 | Class 2 | 2025-06-09 |
| K251230 | The Alma Hybrid Laser SystemSurgical cutting | Alma Lasers, Inc.United States | CO2 | Class 2 | 2025-05-21 |
| K250183 | CO2 Laser System (CO2 Laser SST-L23)Surgical cutting | Zhuozhou Summer Star Technologies Co., Ltd.China | CO2 | Class 2 | 2025-04-24 |
| K243588 | Single Use CO2 Laser Fiber (HAF005001)Surgical cutting | Quanta System SpaItaly | CO2 | Class 2 | 2025-02-19 |
| K242941 | CO2 Laser Therapy Systems (SHE-LSP003-1)Surgical cutting | Beijing Sano Laser S&T Development Co.,LtdChina | CO2 | Class 2 | 2025-01-27 |
| 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 |
| K242183 | Fractional CO2 Laser Therapy System (EXFU CO2)Skin resurfacing | Weifang Mingliang Electronics Co., Ltd.China | CO2 | Class 2 | 2024-10-23 |
| K241092 | Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTSurgical cutting | Quanta System SpaItaly | CO2 | Class 2 | 2024-10-10 |
| K241672 | COPRO 3Surgical cutting | Amt Engineering Co., Ltd.Korea, Republic of | CO2 | Class 2 | 2024-09-06 |
| K241600 | DermablateSkin resurfacing | Asclepion Laser Technologies GmbHUnited States | CO2 | Class 2 | 2024-07-03 |
| K233803 | UltraClear Laser System (N/A)Skin resurfacing | Acclaro CorporationUnited States | CO2 | Class 2 | 2024-05-08 |
| K232133 | Co2 Laser System, Models: PureLase And VanLaseSurgical cutting | Cpmt Laser (Canadian Pioneer Medical Technology Corporation)Canada | CO2 | Class 2 | 2024-04-16 |
| K234085 | LUNE™ PureHygieneDental | Enamel PureUnited States | CO2 | Class 2 | 2024-03-25 |
| 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 |
| K231514 | AzureSurgical cutting | Daeshin Enterprise Co., Ltd.Korea, Republic of | CO2 | Class 2 | 2024-02-14 |
| K233301 | ULTRApulse Alpha CO2 Laser System, Delivery Devices and AccessoriesSurgical cutting | Lumenis Be, Ltd.Israel | CO2 | Class 2 | 2023-12-01 |
| K223727 | LavieenPigment treatment | Wontech Co., Ltd.Korea, Republic of | CO2 | Class 2 | 2023-08-25 |
| K230268 | ZenPro 40Surgical cutting | BLUECORE COMPANY Co., Ltd.Korea, Republic of | CO2 | Class 2 | 2023-08-10 |
| K230077 | LaserMESkin resurfacing | Neauvia North AmericaUnited States | CO2 | Class 2 | 2023-07-17 |
| K231309 | SCAR 3Skin resurfacing | El.En Electroinc Engineering SpaItaly | CO2 | Class 2 | 2023-06-02 |
| K213669 | LIGHTSCALPEL LS-4020Surgical cutting | Lightscalpel, Inc.United States | CO2 | Class 2 | 2023-02-15 |
| K222221 | DEKA HELIXSurgical cutting | El.En Electronic Engineering SpaItaly | CO2 | Class 2 | 2023-01-04 |
| 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 |
| 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 |
| 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 |
| K212611 | CO2 Laser EquipmentSurgical cutting | Beijing Globalipl Development Co., Ltd.China | CO2 | Class 2 | 2022-02-01 |
| K210847 | UltraClear Fractional Laser SystemSkin resurfacing | Fa International, LPUnited States | CO2 | Class 2 | 2021-12-10 |
| K211735 | CO2 Laser Machine, Model: BW-203BSurgical cutting | Zhengzhou Bestview ST Co., Ltd.China | CO2 | Class 2 | 2021-10-22 |
| K212703 | AcuPulse CO2 Laser System, Delivery Devices and AccessoriesSurgical cutting | Lumenis, Inc.Israel | CO2 | Class 2 | 2021-10-19 |
| K203799 | ProFlex CO2 Laser FiberSurgical cutting | Innovaquartz, LLCUnited States | CO2 | Class 2 | 2021-09-20 |
| K211362 | SCAR 3Surgical cutting | El.En Electronic Engineering SpaItaly | CO2 | Class 2 | 2021-08-25 |
| K211761 | UltraLase Flexible CO2 Laser WaveguideSurgical cutting | W & R Investments, LLC Dba Laser EngineeringUnited States | CO2 | Class 2 | 2021-07-30 |
| K203441 | The Alma Hybrid Laser SystemSurgical cutting | Alma Lasers, Inc.Israel | CO2 | Class 2 | 2021-07-02 |
| K203241 | OmniGuide BeamPath OTO-U FiberSurgical cutting | Omniguide, Inc.United States | CO2 | Class 2 | 2021-01-14 |
| K203544 | UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and AccessoriesSurgical cutting | Lumenis, Inc.Israel | CO2 | Class 2 | 2020-12-24 |
| K202250 | Dermatological Carbon Dioxide Laser SystemsSurgical cutting | Zhuolu Jontelaser Manufacturing Technology Co., Ltd.China | CO2 | Class 2 | 2020-11-25 |
| K202428 | AcuPulse W CO2 Laser Systems, Delivery Devices and AccessoriesSkin resurfacing | Lumenis, Inc.Israel | CO2 | Class 2 | 2020-10-22 |
| K201663 | AcuPulse W CO2 Laser Systems, Delivery Devices and AccessoriesSurgical cutting | Lumenis, Inc.Israel | CO2 | Class 2 | 2020-07-16 |
| K201109 | CO2 Laser Therapy SystemSurgical cutting | Shanghai Apolo Medical Technology Co., Ltd.China | CO2 | Class 2 | 2020-07-15 |