510(k) submissions
Filtered by Thulium fiber · showing 1–18 of 18
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| 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 |
| 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 |
| K251303 | Tamburo Thulium Fiber Laser SystemSurgical cutting | Menovex Medical Technology (Shenzhen) Co., Ltd.China | Thulium fiber | Class 2 | 2025-11-04 |
| K253100 | MultiPulse TFLSurgical cutting | Asclepion Laser Technologies GmbHUnited States | Thulium fiber | Class 2 | 2025-10-23 |
| K252732 | 1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)Pigment treatment | Zhengzhou PZ Laser Slim Technology Co., Ltd.China | Thulium fiber | Class 2 | 2025-10-23 |
| K251919 | Thulium Laser System (Deluxlase)Pigment treatment | Nanjing Bestview Laser S&T Co., Ltd.China | Thulium fiber | Class 2 | 2025-09-26 |
| K251100 | IPGTFL-02Other | Ipg Medical CorporationUnited States | Thulium fiber | Class 2 | 2025-09-19 |
| 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 |
| 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 |
| K241406 | LavieenPigment treatment | Wontech Co., Ltd.Korea, Republic of | Thulium fiber | Class 2 | 2024-06-28 |
| K232568 | IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and AccessoriesSurgical cutting | Ipg Medical CorporationUnited States | Thulium fiber | Class 2 | 2024-03-21 |
| 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 |
| K213252 | Dornier ThulioSurgical cutting | Dornier Medtech America, Inc.United States | Thulium fiber | Class 2 | 2022-07-27 |
| 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 |
| K192331 | LaseMD LEO Laser SystemPigment treatment | Lutronic GlobalUnited States | Thulium fiber | Class 2 | 2019-11-12 |
| K183647 | 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 | 2019-08-09 |
| K182173 | Joule SystemPigment treatment | Sciton, IncUnited States | Thulium fiber | Class 2 | 2019-03-06 |