510(k) submissions
Filtered by Other · showing 1–50 of 89
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| 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 |
| 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 |
| K254271 | CAPRISurgical cutting | ORO Co., Ltd.Korea, Republic of | Diode | Class 2 | 2026-02-26 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| K250776 | Lithoblast Single Use Holmium Laser FibersSurgical cutting | Dawell Medical, LLCUnited States | Er:YAG | Class 2 | 2025-10-14 |
| 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 |
| K251727 | GLAM LED Facial Mask (TB-2386F)Acne treatment | Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.China | LED | Class 2 | 2025-08-29 |
| K250261 | Heager Medical Laser Family (Sabrina/Adolf)Surgical cutting | Heager GmbHUnited States | Diode | Class 2 | 2025-08-26 |
| 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 |
| K243701 | AuroLase® SystemSurgical cutting | Nanospectra Biosciences, Inc.United States | Diode | Class 2 | 2025-07-02 |
| K243683 | Deka BluebeamSurgical cutting | El.En S.P.A.Italy | Diode | Class 2 | 2025-06-12 |
| K250113 | neoLaser Laser Surgery FibersSurgical cutting | G.N.S Neolaser , Ltd.Israel | Laser fiber / delivery | Class 2 | 2025-03-13 |
| K243993 | Photon Therapy Apparatus (BL-10)Pigment treatment | Xemis Medical Technology (Shenzhen) Co., Ltd.China | LED | Class 2 | 2025-03-13 |
| K242207 | NOABLE LASERSurgical cutting | Daeju Meditech Engineering Co., Ltd.Korea, Republic of | Diode | Class 2 | 2025-03-07 |
| 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 |
| 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 |
| 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 |
| K241771 | Liftendo; Liftendo 2.0Surgical cutting | Medical San Indústria DE Equipamentos Médicos Ltda.Brazil | Diode | Class 2 | 2024-09-16 |
| K242251 | Litho 60; Litho 100; Litho 150Surgical cutting | Quanta System SpaItaly | Holmium (Ho:YAG) | Class 2 | 2024-09-03 |
| 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 |
| K241293 | LED Light Therapy Device, ELIXIR MD™Acne treatment | Yassen Wellness, LLCUnited States | LED | Class 2 | 2024-07-08 |
| K241406 | LavieenPigment treatment | Wontech Co., Ltd.Korea, Republic of | Thulium fiber | Class 2 | 2024-06-28 |
| K240222 | Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024)Acne treatment | Aesthetic Technology, Ltd.United Kingdom | LED | Class 2 | 2024-06-04 |
| K240159 | InnoVoyce VYLOSurgical cutting | InnovoyceUnited States | Diode | Class 2 | 2024-05-29 |
| K233157 | VaporMAX LDD; MOJo LDD; MegaJOULE LDDSurgical cutting | Innovaquartz, LLCUnited States | Laser fiber / delivery | Class 2 | 2024-05-03 |
| K234085 | LUNE™ PureHygieneDental | Enamel PureUnited States | CO2 | Class 2 | 2024-03-25 |
| K232568 | IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and AccessoriesSurgical cutting | Ipg Medical CorporationUnited States | Thulium fiber | Class 2 | 2024-03-21 |
| K231876 | MultiPulse HoPLUSSurgical cutting | Asclepion Laser Technologies GmbHUnited States | Holmium (Ho:YAG) | Class 2 | 2024-02-22 |
| K233804 | Resonic Rapid Acoustic Pulse DeviceOther | Zeltiq Aesthetics, Inc.United States | Q-Switched | Class 2 | 2024-02-01 |
| K232106 | Air Gap FiberSurgical cutting | Wontech Co., Ltd.Korea, Republic of | Laser fiber / delivery | Class 2 | 2024-01-08 |
| 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 |
| K232236 | EchoHair removal | Quanta System SpaItaly | Diode | Class 2 | 2023-10-20 |
| K231894 | LED Spectrum therapy instrumentAcne treatment | Shenzhenshi Sincoheren S&T Development Co., Ltd.China | LED | Class 2 | 2023-09-20 |
| K230535 | KARL STORZ Urological Laser AccessoriesSurgical cutting | Karl Storz SE & CO. KGUnited States | Laser fiber / delivery | Class 2 | 2023-09-08 |
| K231718 | Holmium Medical LaserSurgical cutting | Allengers Global Healthcare Private LimitedIndia | Holmium (Ho:YAG) | Class 2 | 2023-08-18 |
| K230342 | Phototherapy System (OL-PDT950)Acne treatment | Shanghai Omni Laser Skinology Co., Ltd.China | LED | Class 2 | 2023-08-16 |
