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GEX

Powered Laser Surgical Instrument

产品代码
GEX
器械名称
Powered Laser Surgical Instrument
管理类别
第 2 类（Class II）
21 CFR 条款
21 CFR 878.4810
FDA 专业组
General, Plastic Surgery
上市路径
需提交 510(k) 上市前通告
标记
可走第三方审查
该代码近三年的 510(k)
2876 件

FDA 分类定义

A laser (light amplification by stimulated emission of radiation) based device having coherence, collimated and typically monochromatic radiation. Typically indicated to to cut, destroy, remove or coagulate tissue, generally soft tissue, for general surgical purpose in medical specialties of general and plastic surgery, dermatology/aesthetic, podiatry, otolaryngology (ent), gynecology, neurosurgery, orthopedics (soft tissue), dental and oral surgery, and dentistry. The classification regulation 21 cfr 878.4810 describes a device that is carbon dioxide or argon laser intended to cut, destroy, remove or coagulate tissue by the light.

定义原文来自 FDA 器械分类库，属美国联邦政府作品（公有领域）。

该代码近三年的 510(k)（221 件）

数据窗口为最近三年。最新一件：2026-08-27。

510(k) 号批准日期申请人器械名称
K2618212026-08-27Zhengzhou PZ Laser Slim Technology Co.1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02) 摘要
K2619642026-08-19Elesta S.P.AECHOLASER X4 摘要
K2620702026-08-19Hebei Zollvan Medical Technology Co., Diode Laser Therapy Systems (DL612A) 摘要
K2618412026-08-11Beijing Nubway S&T Co., Ltd.Q Switched Nd:YAG Laser machine (QLQW-01) 摘要
K2612212026-07-24Olympus Surgical Technologies AmericaSOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Lase 摘要
K2617382026-07-21Rhein Laser Technologies Co., Ltd.Medical Thulium Fiber Laser Systems (UroFiber 150Q) 摘要
K2616932026-07-17Beijing Nubway S&T Co., Ltd.Diode laser hair removal machine (QDTM-04) 摘要
K2616742026-07-16Beijing Nubway S&T Co., Ltd.Skin Air Cooling System (QALF-01) 摘要
K2617012026-06-18Micro-Energy Medical Technology Co., LHemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo 摘要
K2615702026-06-17Cynosure, LLCPICOSURE WORKSTATION 摘要
K2606902026-06-04Beijing Sano Laser S&T Development Co.LumiGlam Laser System (SHE-LSP601-3)
K2604892026-05-29Eufoton S.R.L.LASEmaR 1500 摘要
K2601382026-05-29Enamel PureLUNE PureHygiene 摘要
K2532452026-05-21Boston Aesthetics, Inc.Boston 2910 (Boston 2910) 摘要
K2601002026-05-18Boston Scientific CorporationMOSES Raydar™ 摘要
K2612142026-05-11Speclipse, Inc.PICO SHINING (PICO-K; PICOFY) 摘要
K2609742026-05-07Nanjing Bestview Laser S&T Co., Ltd.CO2 Laser Machine (Monica-I,Monica-II) 摘要
K2602562026-05-04Shanghai Apolo Medical Technology Co.,Q-Switched Nd: YAG Laser Systems 摘要
K2532512026-05-04Leaseir Technologies, SluLeaseir MHR Xcell (console) (MHR-100b); Handpiece: 摘要
K2610942026-04-29Asclepion Laser Technologies GmbHYellowStar 摘要
K2537652026-04-22Ddc Technologies, Inc.VANISH PRO 摘要
K2601532026-04-20Nanjing Bestview Laser S&T Co., Ltd.Q-Switched Nd: YAG Laser System (Glamor Q) 摘要
K2603072026-04-15Weifang Mingliang Electronics Co., LtdDiode Laser Therapy Systems (V19) 摘要
K2600172026-04-09Shanghai Apolo Medical Technology Co.,Picosecond Nd:YAG Laser Systems (Model: HS-298) 摘要
K2603752026-03-31Sanhe Meditech Co., Ltd.Nd: YAG Laser Therapy Systems 摘要
K2602572026-03-28Sanhe Meditech Co., Ltd.CO2 Laser System 摘要
K2529712026-03-17C.R. Bard, Inc.Elyra™ Thulium Fiber Laser System and Elyra™ Plus Th 摘要
K2606322026-03-17Elesta S.P.ALASER THERMAL THERAPY KIT 摘要
K2541972026-03-11CAO Group, Inc.Picasso Pro Diode Laser (002-00460) 摘要
K2539512026-03-06Guangzhou Potent Medical Equipment JoiHolmium Laser Therapeutic Apparatus (HZ-A); Holmium 摘要
K2539202026-03-03Haidari Beauty Technology (Beijing) CoCO2 Laser Treatment Machine (CFR3M1) 摘要
K2538292026-02-27Beijing HuaCheng Taike Technology Co.,Medical Ultra-Pico Laser Treatment System (CM-SP-106 摘要
K2538282026-02-27Beijing HuaCheng Taike Technology Co.,Medical Alexandrite and Nd:YAG laser Therapy System 摘要
K2542712026-02-26ORO Co., Ltd.CAPRI 摘要
K2525992026-02-24Wingderm Electro-Optics , Ltd.Diode Laser Therapy Systems (WLA-02) 摘要
K2525612026-02-18BTL Industries, Inc.BTL-754FF 摘要
K2520482026-02-03Xi'An Taibo Electronic Technology Co.,808nm semiconductor laser hair removal machine 摘要
K2519812026-01-30Boston Aesthetics, Inc.Boston PICO (Boston PICO) 摘要
K2527532026-01-24Vydence Medical Industria E Commercio Vydence Family of Lasers 摘要
K2536332026-01-24Guangzhou Potent Medical Equipment JoiHolmium Laser Therapeutic Apparatus (HZ-40) 摘要
K2523692026-01-21Boston Aesthetics, Inc.Boston Pico755 摘要
K2533422025-12-24Speclipse, Inc.PICO-K 摘要
K2528772025-12-19Wontech Co., Ltd.SANDRO Dual 摘要
K2510772025-12-19Sciton, IncJOULE 1064nm System and Accessories 摘要
K2509982025-12-19Sanhe Lefis Electronics Co., Ltd.CO2 Laser Therapy System (Model: LFS-D9U) 摘要
K2527452025-12-12Micro-Energy Medical Technology Co., LHalo Sterile Single-use Radial Fiber (Halo-R-0.40-2. 摘要
K2526582025-11-28Baoding Te'Anzhou Electronic TechnologMedical Diode Laser Systems (TR-B) 摘要
K2533442025-11-25Speclipse, Inc.BELLUS-Q 摘要
K2532192025-11-25Shenzhen Leaflife Technology Co., Ltd.LeafPure-Echo (LM-LPNdA)
K2527872025-11-24Guangzhou Potent Medical Equipment JoiThulium Fiber Laser System (TFL-A); Thulium Fiber La 摘要
K2527712025-11-24Guangzhou Potent Medical Equipment JoiHolmium Laser System (Potent HP90); Holmium Laser Sy 摘要
K2530072025-11-20Guangzhou Potent Medical Equipment JoiLaser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); La 摘要
K2531232025-11-20Classys, Inc.CuRAS hybrid 摘要
K2525192025-11-07Hebei Keylaser Sci-Tech Co.,LtdCO2 Laser Therapy System (K106) 摘要
K2525642025-11-07Baoding Te'Anzhou Electronic TechnologMedical Diode Laser Systems (VeinCure) 摘要
K2525152025-11-06Hebei Keylaser Sci-Tech Co.,LtdQ-Switched Nd:Yag laser (K690) 摘要
K2513032025-11-04Menovex Medical Technology (Shenzhen) Tamburo Thulium Fiber Laser System 摘要
K2524272025-10-31Sanhe Meditech Co., Ltd.Diode Laser Hair Removal Machine (GLD01) 摘要
K2525292025-10-30Boston Scientific CorporationMoses™ 200 D/F/L Laser Fiber (M0068130100); Moses™ 3 摘要
K2518242025-10-27Patriot Laser, LLCPatriot Duo 摘要
K2531002025-10-23Asclepion Laser Technologies GmbHMultiPulse TFL 摘要
K2523452025-10-23Risu Medical Technology Co., Ltd.Picosecond Laser Device (PF131-BI) 摘要
K2527322025-10-23Zhengzhou PZ Laser Slim Technology Co.1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-0 摘要
K2523192025-10-20Sanhe Lefis Electronics Co., Ltd.Q-Switched Nd: YAG Laser machine (LFS-C13U) 摘要
K2507762025-10-14Dawell Medical, LLCLithoblast Single Use Holmium Laser Fibers 摘要
K2516992025-10-08Bellamia Technologies, Inc.The Botticelli (Model: Athena) 摘要
K2429462025-10-03Senbitec Co., Ltd.HESTIA (L200-A) 摘要
K2514642025-10-03Jeisys Medical IncorporatedTRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit) 摘要
K2524472025-10-01Hebei Newangie Technology Co., Ltd.Picosecond laser device (BMPS4) 摘要
K2519192025-09-26Nanjing Bestview Laser S&T Co., Ltd.Thulium Laser System (Deluxlase) 摘要
K2520632025-09-25Wuhan Dimed Laser Technology Co., Ltd.Medical Diode Laser Systems (BERYLAS-12N); Medical D 摘要
K2500712025-09-24Alma Lasers, Inc.Alma FemiLift Pixel CO2 Laser System, Delivery Devic 摘要
K2428592025-09-19Ibramed Equipamentos MédicosVEGA 摘要
K2511002025-09-19Ipg Medical CorporationIPGTFL-02 摘要
K2514572025-09-03Beijing Superlaser Technology Co., LtdDiode laser therapy device (VADER) 摘要
K2517272025-08-29Touchbeauty Beauty & Health (Shenzhen)GLAM LED Facial Mask (TB-2386F) 摘要
K2502612025-08-26Heager GmbHHeager Medical Laser Family (Sabrina/Adolf) 摘要
K2518012025-08-08Hebei Newangie Technology Co., Ltd.Diode laser device (BM091) 摘要
K2514322025-08-06El.En S.P.A.Olo 摘要
K2510762025-07-30Shenzhen Lifotronic Technology Co., LtDiode Laser Hair Removal Machine (models: T60A, T60B 摘要
K2513392025-07-25Zhengzhou PZ Laser Slim Technology Co.Medical Diode Laser Hair Removal Device (PZ-606¿, PZ 摘要
K2505042025-07-14Ceramoptec GmbHLeonardo Duster 摘要
K2511492025-07-11Cutera, Inc.AviClear Laser System 摘要
K2517592025-07-09Boston Scientific CorporationFlexiva Pulse Laser Fiber; Flexiva Pulse TracTip Las 摘要
K2501652025-07-03Wontech Co., Ltd.Pastelle 摘要
K2437012025-07-02Nanospectra Biosciences, Inc.AuroLase® System 摘要
K2510492025-07-02Micro-Energy Medical Technology Co., LSurgiLight 1470 Diode Laser System (Model:Halo) 摘要
K2513292025-06-27Risu Medical Technology Co., Ltd.Diode laser device (RF3120-BI) 摘要
K2516322025-06-26InMode , Ltd.Optimas MAX System 摘要
K2436832025-06-12El.En S.P.A.Deka Bluebeam 摘要
K2507822025-06-12Zhengzhou PZ Laser Slim Technology Co.Fractional CO2 Laser Machine 摘要
K2509362025-06-12Beijing Sano Laser S&T Development Co.Q-Switched Nd:YAG Laser (SHE-LSP101-1) 摘要
K2504652025-06-09Nanjing Bestview Laser S&T Co., Ltd.CO2 Laser Machine (Lume) 摘要
K2409832025-06-06Quanta System SpaDiscovery Pico; Discovery Pico Plus; Discovery Pico 摘要
K2507222025-06-06Hebei JT Medical Co., Ltd.Nd: YAG Laser Therapy System (QN-1) 摘要
K2501952025-05-30Matelaser, Inc.MateLaser Medical Laser Therapy Systems (ML-HIL-30,
K2512302025-05-21Alma Lasers, Inc.The Alma Hybrid Laser System 摘要
K2500412025-05-14Zhengzhou PZ Laser Slim Technology Co.Medical Picosecond ND: YAG Laser System (PZ-6) 摘要
K2512882025-05-14Wontech Co., Ltd.Veincare 摘要
K2504312025-05-12Shandong Moonlight Electronics Tech CoMedical Diode Laser Hair Removal System (MNLT-D1) 摘要
K2510942025-05-06Wontech Co., Ltd.Alma Veil 摘要
K2429512025-04-28Beijing Nubway S&T Co., Ltd.Diode laser hair removal machine (QDTM-02) 摘要
K2501832025-04-24Zhuozhou Summer Star Technologies Co.,CO2 Laser System (CO2 Laser SST-L23) 摘要
K2502062025-04-24Ivylaser (Beijing) Technology Co.,LtdDiode laser system (Night Universe; Predator) 摘要
K2508092025-04-16Lumenis Be, Ltd.Stellar M22 摘要
K2430442025-04-11Alma Lasers, Inc.Alma Harmony 摘要
K2506562025-04-04Wuhan Pioon Technology Co., Ltd.Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75) 摘要
K2500182025-04-01Gigaalaser Company , Ltd.Medical Diode Laser Systems (THEIA808) 摘要
K2501892025-04-01Advalight ApsAdvaTx 摘要
K2436302025-03-21Solar LS CjscMedical Laser System Incanto / Evoline Platinum /Evo 摘要
K2417912025-03-19Gigaalaser Company , Ltd.Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GB 摘要
K2439932025-03-13Xemis Medical Technology (Shenzhen) CoPhoton Therapy Apparatus (BL-10) 摘要
K2501132025-03-13G.N.S Neolaser , Ltd.neoLaser Laser Surgery Fibers 摘要
K2439572025-03-12Wontech Co., Ltd.PICOALEX 摘要
K2422072025-03-07Daeju Meditech Engineering Co., Ltd.NOABLE LASER 摘要
K2429432025-03-03Beijing Nubway S&T Co., Ltd.Q Switched Nd:YAG Laser machine (QNHF-01) 摘要
K2340042025-02-20Reveal Lasers , Ltd.Medical diode laser systems (CHARISMA, REGAL) 摘要
K2435882025-02-19Quanta System SpaSingle Use CO2 Laser Fiber (HAF005001) 摘要
K2415272025-02-14Wontech Co., Ltd.Pastelle Pro 摘要
K2416432025-02-14Wontech Co., Ltd.WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA 摘要

另有 101 件未列出。

FDA 官方分类页： GEX
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。