510(k) submissions
All indexed GEX clearances · showing 1–50 of 667
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| K253245 | Boston 2910 (Boston 2910) | Boston Aesthetics, Inc.United States | — | Class 2 | 2026-05-21 |
| K260100 | MOSES Raydar™ | Boston Scientific CorporationUnited States | — | Class 2 | 2026-05-18 |
| K261214 | PICO SHINING (PICO-K; PICOFY)Pigment treatment | Speclipse, Inc.Korea, Republic of | Picosecond | Class 2 | 2026-05-11 |
| K260974 | CO2 Laser Machine (Monica-I,Monica-II)Skin resurfacing | Nanjing Bestview Laser S&T Co., Ltd.China | CO2 | Class 2 | 2026-05-07 |
| K260256 | Q-Switched Nd: YAG Laser SystemsPigment treatment | Shanghai Apolo Medical Technology Co., Ltd.China | Q-Switched | Class 2 | 2026-05-04 |
| K253251 | Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece: Quad (810-b and Blend-b)Hair removal | Leaseir Technologies, SluSpain | Diode | Class 2 | 2026-05-04 |
| K261094 | YellowStarVascular treatment | Asclepion Laser Technologies GmbHUnited States | Diode | Class 2 | 2026-04-29 |
| K253765 | VANISH PROPigment treatment | Ddc Technologies, Inc.United States | Nd:YAG | Class 2 | 2026-04-22 |
| K260153 | Q-Switched Nd: YAG Laser System (Glamor Q)Pigment treatment | Nanjing Bestview Laser S&T Co., Ltd.China | Q-Switched | Class 2 | 2026-04-20 |
| K260307 | Diode Laser Therapy Systems (V19)Hair removal | Weifang Mingliang Electronics Co., Ltd.China | Diode | Class 2 | 2026-04-15 |
| K260017 | Picosecond Nd:YAG Laser Systems (Model: HS-298)Pigment treatment | Shanghai Apolo Medical Technology Co., Ltd.China | Nd:YAG | Class 2 | 2026-04-09 |
| 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 |
| K253828 | Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP)Hair removal | Beijing HuaCheng Taike Technology Co., Ltd.China | Alexandrite | Class 2 | 2026-02-27 |
| K254271 | CAPRISurgical cutting | ORO Co., Ltd.Korea, Republic of | Diode | Class 2 | 2026-02-26 |
| K252599 | Diode Laser Therapy Systems (WLA-02)Hair removal | Wingderm Electro-Optics , Ltd.China | Diode | Class 2 | 2026-02-24 |
| K252561 | BTL-754FFSkin resurfacing | BTL Industries, Inc.United States | Er:YAG | Class 2 | 2026-02-18 |
| K252048 | 808nm semiconductor laser hair removal machineHair removal | Xi'An Taibo Electronic Technology Co., Ltd.China | Diode | Class 2 | 2026-02-03 |
| K251981 | Boston PICO (Boston PICO)Pigment treatment | Boston Aesthetics, Inc.United States | Picosecond | Class 2 | 2026-01-30 |
| 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 |
| K252753 | Vydence Family of LasersHair removal | Vydence Medical Industria E Commercio LtdaBrazil | Nd:YAG | Class 2 | 2026-01-24 |
| K252369 | Boston Pico755Pigment treatment | Boston Aesthetics, Inc.United States | Picosecond | Class 2 | 2026-01-21 |
| K253342 | PICO-KPigment treatment | Speclipse, Inc.Korea, Republic of | Picosecond | Class 2 | 2025-12-24 |
| K252877 | SANDRO DualHair removal | Wontech Co., Ltd.Korea, Republic of | Alexandrite | Class 2 | 2025-12-19 |
| 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 |
| K253219 | LeafPure-Echo (LM-LPNdA)Pigment treatment | Shenzhen Leaflife Technology Co., Ltd.China | Nd:YAG | 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 |
| K252564 | Medical Diode Laser Systems (VeinCure)Vascular treatment | Baoding Te'Anzhou Electronic Technology Co., Ltd.China | Diode | Class 2 | 2025-11-07 |
| K252519 | CO2 Laser Therapy System (K106)Surgical cutting | Hebei Keylaser Sci-Tech Co.,LtdChina | CO2 | Class 2 | 2025-11-07 |
| K252515 | Q-Switched Nd:Yag laser (K690)Pigment treatment | Hebei Keylaser Sci-Tech Co.,LtdChina | Nd:YAG | Class 2 | 2025-11-06 |
| K251303 | Tamburo Thulium Fiber Laser SystemSurgical cutting | Menovex Medical Technology (Shenzhen) Co., Ltd.China | Thulium fiber | Class 2 | 2025-11-04 |
| K252427 | Diode Laser Hair Removal Machine (GLD01)Hair removal | Sanhe Meditech Co., Ltd.China | Diode | Class 2 | 2025-10-31 |
| 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 |
| K252345 | Picosecond Laser Device (PF131-BI)Pigment treatment | Risu Medical Technology Co., Ltd.China | Picosecond | Class 2 | 2025-10-23 |
