510(k) submissions
Filtered by Surgical cutting · showing 1–50 of 340
| 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 |
| K260375 | Nd: YAG Laser Therapy SystemsPigment treatment | Sanhe Meditech Co., Ltd.China | Nd:YAG | Class 2 | 2026-03-31 |
| K260257 | CO2 Laser SystemSurgical cutting | Sanhe Meditech Co., Ltd.China | CO2 | Class 2 | 2026-03-28 |
| K260632 | LASER THERMAL THERAPY KITSurgical cutting | Elesta S.P.AItaly | Nd:YAG | Class 2 | 2026-03-17 |
| K252971 | Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories)Surgical cutting | C.R. Bard, Inc.United States | Thulium fiber | Class 2 | 2026-03-17 |
| K254197 | Picasso Pro Diode Laser (002-00460)Surgical cutting | CAO Group, Inc.United States | Diode | Class 2 | 2026-03-11 |
| K253951 | Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B); Holmium Laser Therapeutic Apparatus (HZ-E)Surgical cutting | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.China | Nd:YAG | Class 2 | 2026-03-06 |
| K253920 | CO2 Laser Treatment Machine (CFR3M1)Surgical cutting | Haidari Beauty Technology (Beijing) Co., Ltd.China | CO2 | Class 2 | 2026-03-03 |
| K253829 | Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Pigment treatment | Beijing HuaCheng Taike Technology Co., Ltd.China | Picosecond | Class 2 | 2026-02-27 |
| K254271 | CAPRISurgical cutting | ORO Co., Ltd.Korea, Republic of | Diode | Class 2 | 2026-02-26 |
| K252561 | BTL-754FFSkin resurfacing | BTL Industries, Inc.United States | Er:YAG | Class 2 | 2026-02-18 |
| K253633 | Holmium Laser Therapeutic Apparatus (HZ-40)Surgical cutting | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.China | Nd:YAG | Class 2 | 2026-01-24 |
| K251077 | JOULE 1064nm System and AccessoriesVascular treatment | Sciton, IncUnited States | Nd:YAG | Class 2 | 2025-12-19 |
| K250998 | CO2 Laser Therapy System (Model: LFS-D9U)Skin resurfacing | Sanhe Lefis Electronics Co., Ltd.China | CO2 | Class 2 | 2025-12-19 |
| 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 |
| K253344 | BELLUS-QSurgical cutting | Speclipse, Inc.Korea, Republic of | Q-Switched | Class 2 | 2025-11-25 |
| K252787 | Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B)Surgical cutting | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.China | Thulium fiber | Class 2 | 2025-11-24 |
| K252771 | Holmium Laser System (Potent HP90); Holmium Laser System (Potent HP100); Holmium Laser System (Potent HP9120); Holmium Laser System (Potent HP140); Holmium Laser System (Potent HP150)Surgical cutting | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.China | Er:YAG | Class 2 | 2025-11-24 |
| K253123 | CuRAS hybridSurgical cutting | Classys, Inc.Korea, Republic of | Nd:YAG | Class 2 | 2025-11-20 |
| K253007 | Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber (PT-OF-D-S); Laser Fiber (PT-OF-E-S); Laser Fiber (PT-OF-F-S)Surgical cutting | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.China | Laser fiber / delivery | Class 2 | 2025-11-20 |
| K252519 | CO2 Laser Therapy System (K106)Surgical cutting | Hebei Keylaser Sci-Tech Co.,LtdChina | CO2 | Class 2 | 2025-11-07 |
| K251303 | Tamburo Thulium Fiber Laser SystemSurgical cutting | Menovex Medical Technology (Shenzhen) Co., Ltd.China | Thulium fiber | Class 2 | 2025-11-04 |
| K252529 | Moses™ 200 D/F/L Laser Fiber (M0068130100); Moses™ 365 D/F/L Laser Fiber (M0068130110); Moses™ 550 D/F/L Laser Fiber (M0068130120)Surgical cutting | Boston Scientific CorporationUnited States | Laser fiber / delivery | Class 2 | 2025-10-30 |
| K251824 | Patriot DuoSurgical cutting | Patriot Laser, LLCUnited States | Laser fiber / delivery | Class 2 | 2025-10-27 |
| K253100 | MultiPulse TFLSurgical cutting | Asclepion Laser Technologies GmbHUnited States | Thulium fiber | Class 2 | 2025-10-23 |
| K252319 | Q-Switched Nd: YAG Laser machine (LFS-C13U)Pigment treatment | Sanhe Lefis Electronics Co., Ltd.China | Nd:YAG | Class 2 | 2025-10-20 |
| K250776 | Lithoblast Single Use Holmium Laser FibersSurgical cutting | Dawell Medical, LLCUnited States | Er:YAG | Class 2 | 2025-10-14 |
| K251464 | TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Surgical cutting | Jeisys Medical IncorporatedKorea, Republic of | Nd:YAG | Class 2 | 2025-10-03 |
| K242946 | HESTIA (L200-A)Surgical cutting | Senbitec Co., Ltd.Korea, Republic of | CO2 | Class 2 | 2025-10-03 |
| K252447 | Picosecond laser device (BMPS4)Pigment treatment | Hebei Newangie Technology Co., Ltd.China | Picosecond | Class 2 | 2025-10-01 |
| 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 |
| K250071 | Alma FemiLift Pixel CO2 Laser System, Delivery Devices and AccessoriesSurgical cutting | Alma Lasers, Inc.United States | CO2 | Class 2 | 2025-09-24 |
| K250261 | Heager Medical Laser Family (Sabrina/Adolf)Surgical cutting | Heager GmbHUnited States | Diode | Class 2 | 2025-08-26 |
| K250504 | Leonardo DusterSurgical cutting | Ceramoptec GmbHUnited States | Other | Class 2 | 2025-07-14 |
| K251759 | Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser FibersSurgical cutting | Boston Scientific CorporationUnited States | Laser fiber / delivery | Class 2 | 2025-07-09 |
| K250165 | PastelleSurgical cutting | Wontech Co., Ltd.Korea, Republic of | Nd:YAG | Class 2 | 2025-07-03 |
| 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 |
| K250936 | Q-Switched Nd:YAG Laser (SHE-LSP101-1)Pigment treatment | Beijing Sano Laser S&T Development Co.,LtdChina | Nd:YAG | Class 2 | 2025-06-12 |
| K250782 | Fractional CO2 Laser MachineSkin resurfacing | Zhengzhou PZ Laser Slim Technology Co., Ltd.China | CO2 | Class 2 | 2025-06-12 |
| K243683 | Deka BluebeamSurgical cutting | El.En S.P.A.Italy | Diode | 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 |
| K240983 | Discovery Pico; Discovery Pico Plus; Discovery Pico DermPigment treatment | Quanta System SpaItaly | Q-Switched | Class 2 | 2025-06-06 |
| K251230 | The Alma Hybrid Laser SystemSurgical cutting | Alma Lasers, Inc.United States | CO2 | Class 2 | 2025-05-21 |
| K251094 | Alma VeilVascular treatment | Wontech Co., Ltd.Korea, Republic of | Nd:YAG | Class 2 | 2025-05-06 |
| K250183 | CO2 Laser System (CO2 Laser SST-L23)Surgical cutting | Zhuozhou Summer Star Technologies Co., Ltd.China | CO2 | 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 |
| 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 |
| K250113 | neoLaser Laser Surgery FibersSurgical cutting | G.N.S Neolaser , Ltd.Israel | Laser fiber / delivery | Class 2 | 2025-03-13 |
