510(k) submissions
Filtered by Laser fiber / delivery · showing 1–22 of 22
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| K250113 | neoLaser Laser Surgery FibersSurgical cutting | G.N.S Neolaser , Ltd.Israel | Laser fiber / delivery | Class 2 | 2025-03-13 |
| 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 |
| K243147 | LGO-Surgical Laser FibersSurgical cutting | Light Guide Optics International , Ltd.Latvia | Laser fiber / delivery | Class 2 | 2024-12-21 |
| K233157 | VaporMAX LDD; MOJo LDD; MegaJOULE LDDSurgical cutting | Innovaquartz, LLCUnited States | Laser fiber / delivery | Class 2 | 2024-05-03 |
| K232106 | Air Gap FiberSurgical cutting | Wontech Co., Ltd.Korea, Republic of | Laser fiber / delivery | Class 2 | 2024-01-08 |
| K232769 | BeaMed Laser Surgery FibersSurgical cutting | Bt Beamedical Tachnoogies Ltd. (Beamed)Israel | Laser fiber / delivery | Class 2 | 2023-12-06 |
| K230535 | KARL STORZ Urological Laser AccessoriesSurgical cutting | Karl Storz SE & CO. KGUnited States | Laser fiber / delivery | Class 2 | 2023-09-08 |
| 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 |
| K230819 | OmniGuide RFID Surgical Laser FibersSurgical cutting | Omni-Guide Holdings, Inc.United States | Laser fiber / delivery | Class 2 | 2023-04-21 |
| K221623 | FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmSkin resurfacing | Gme German Medical Engineering GmbHUnited States | Laser fiber / delivery | Class 2 | 2023-03-10 |
| K211401 | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)Surgical cutting | Gyrus Acmi, Inc.United States | Laser fiber / delivery | Class 2 | 2021-06-03 |
| K210925 | Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser Fiber, Flexiva Pulse ID TracTip Laser FiberSurgical cutting | Boston Scientific CorporationUnited States | Laser fiber / delivery | Class 2 | 2021-04-28 |
| K201171 | LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableSurgical cutting | Leoni Fiber Optics, Inc.United States | Laser fiber / delivery | Class 2 | 2021-04-02 |
| K210142 | Fiber DustSurgical cutting | Quanta System SpaItaly | Laser fiber / delivery | Class 2 | 2021-03-11 |
| K203054 | FlexSysAcne treatment | Gme German Medical Engineering GmbHUnited States | Laser fiber / delivery | Class 2 | 2021-03-05 |
| K202702 | FLARE Single-Use Surgical Laser FiberSurgical cutting | Realton (Suzhou) Medical Technology Co., Ltd.China | Laser fiber / delivery | Class 2 | 2021-02-26 |
| K202601 | Single-use Sterile medical laser fiberSurgical cutting | Realton (Suzhou) Medical Technology Co., Ltd.China | Laser fiber / delivery | Class 2 | 2020-12-15 |
| K200234 | Surgical laser fibersSurgical cutting | Quanta System SpaItaly | Laser fiber / delivery | Class 2 | 2020-02-25 |
