FDA Product Code
FDA Product Code GEX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4810
510(k) Clearances — 2,887 records · page 6 of 29
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K181044 | 400um Perforator and Accessory Vein Ablation Kit | AngioDynamics, Inc. | 2018-07-05 | Traditional | PDF ↗ |
| K180993 | Beacon Advanced CO2 Laser System | Omniguide, Inc. | 2018-06-28 | Traditional | PDF ↗ |
| K173700 | PICOPLUS Laser System | Lutronic Corporation | 2018-06-19 | Traditional | PDF ↗ |
| K180719 | InMode Diolaze System | Inmode MD , Ltd. | 2018-06-14 | Traditional | PDF ↗ |
| K180593 | Vbeam Prima Laser System | Syneron-Candela | 2018-06-05 | Traditional | PDF ↗ |
| K180508 | JOULE SYSTEM | Sciton, Inc | 2018-05-18 | Traditional | PDF ↗ |
| K180922 | Empower H100, Cyber Ho 100, Litho 100 | Quanta System Spa | 2018-05-08 | Special | PDF ↗ |
| K171443 | Etherea MX | Vydence Medical Industria E Comercio Ltda | 2018-04-20 | Traditional | PDF ↗ |
| K180140 | ProFlex Laser Fibers | Innovaquartz, LLC | 2018-04-20 | Traditional | PDF ↗ |
| K180353 | Diode laser hair removal device | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 2018-04-17 | Traditional | PDF ↗ |
| K180597 | AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO | Lumenis, Ltd. | 2018-04-03 | Special | PDF ↗ |
| K180426 | Empower H35 | Quanta System Spa | 2018-03-16 | Special | PDF ↗ |
| K180406 | Ellipse Ydun | Ellipse A/S | 2018-03-15 | Special | PDF ↗ |
| K180224 | ELEMENT-TL | Elemenic Co., Ltd. | 2018-03-15 | Traditional | PDF ↗ |
| K180423 | Empower H65 | Quanta System Spa | 2018-03-15 | Special | PDF ↗ |
| K180044 | SIROLaser Blue | Dentsply Sirona | 2018-03-08 | Traditional | PDF ↗ |
| K172818 | LMT-3000 | Lameditech Co. , Ltd. | 2018-03-07 | Traditional | PDF ↗ |
| K180350 | Dornier Medilas H Solvo 35 Laser | Dornier Medtech America | 2018-03-07 | Special | PDF ↗ |
| K173677 | InMode VLaze | Inmode MD , Ltd. | 2018-02-23 | Traditional | PDF ↗ |
| K173067 | LightForce LTS Model 1000, 1500, 2500, and 4000 | Litecure, LLC | 2018-02-22 | Traditional | PDF ↗ |
| K180193 | DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto) | El.En Electronic Engineering Spa | 2018-02-21 | Special | PDF ↗ |
| K180158 | Surgical Laser fibers | Quanta System Spa | 2018-02-14 | Special | PDF ↗ |
| K172439 | Siberian Fit | Vydence | 2018-02-14 | Traditional | PDF ↗ |
| K173199 | PicoSure Workstation | Cynosure, Inc. | 2018-02-07 | Traditional | PDF ↗ |
| K173285 | JOULE SYSTEM | Sciton, Inc | 2018-01-29 | Traditional | PDF ↗ |
| K172193 | Modified Alma Lasers Soprano XL Family ofMulti-Application & Multi-Technology Platforms [SopranoXL, SopranoXLi, SopranoICE and Soprano ICE Platinum] with Duo and Trio Diode Laser Modules., Soprano Duo and Trio Diode Laser Modules | Alma Lasers, Inc. | 2018-01-09 | Traditional | PDF ↗ |
| K173002 | 2940 nm Er:Yag Laser Handpiece | Quanta System Spa | 2017-12-13 | Traditional | PDF ↗ |
| K172908 | Q-Switched Nd:YAG Laser System | Ami, Inc. | 2017-12-07 | Traditional | PDF ↗ |
| K172819 | LightWalker Laser System Family | Fotona D.O.O. | 2017-12-01 | Traditional | PDF ↗ |
| K173038 | CuRAS Nd:YAG Laser | Ilooda Co,., Ltd. | 2017-12-01 | Traditional | PDF ↗ |
| K172771 | Epic Pro 940 | Biolase, Inc. | 2017-11-29 | Traditional | PDF ↗ |
| K173169 | Rapid Family | Sharplight Technologies, Ltd. | 2017-11-20 | Special | PDF ↗ |
| K173305 | NeuroBlate System | Monteris Medical, | 2017-11-17 | Special | PDF ↗ |
| K172363 | DEKA SMARTXIDE ULTRASPEED | El.En Electronic Engineering Spa | 2017-11-17 | Traditional | PDF ↗ |
| K172362 | DEKA SMARTXIDE TOUCH | El.En Electronic Engineering Spa | 2017-11-17 | Traditional | PDF ↗ |
| K172639 | PALLAS 308/311 Solid-State UV Laser System | Laseroptek Co., Ltd. | 2017-11-03 | Traditional | PDF ↗ |
| K172077 | Cutera enlighten III Laser System | Cutera, Inc. | 2017-10-27 | Traditional | PDF ↗ |
| K172325 | Rhapsody H-30 Holmium Laser System | Cook Incorporated | 2017-10-26 | Traditional | PDF ↗ |
| K172881 | NeuroBlate System | Monteris Medical, | 2017-10-20 | Special | PDF ↗ |
| K172376 | Discovery Pico, Discovery Pico Plus | Quanta System Spa | 2017-10-19 | Traditional | PDF ↗ |
| K172198 | 585 | Quanta System Spa | 2017-10-17 | Traditional | PDF ↗ |
| K172413 | MT ONE | M&T S.R.L. | 2017-10-06 | Traditional | PDF ↗ |
| K171986 | Sterling Supreme Diode Laser | CAO Group, Inc. | 2017-09-22 | Traditional | PDF ↗ |
| K170179 | LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity | Lumenis, Ltd. | 2017-09-18 | Traditional | PDF ↗ |
| K170409 | PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System | Topcon Medical Laser Systems, Inc. (Tmls) | 2017-09-12 | Traditional | PDF ↗ |
| K171648 | BM.IRIS | Bluecore Co., Ltd. | 2017-09-08 | Traditional | PDF ↗ |
| K170970 | Epilaser | Epilady 2000, LLC | 2017-09-01 | Traditional | PDF ↗ |
| K171921 | VenaCure EVLT NeverTouch Procedure Kit | AngioDynamics, Inc. | 2017-08-24 | Traditional | PDF ↗ |
| K171227 | StarWalker | Fotona D.O.O. | 2017-08-18 | Traditional | PDF ↗ |
| K170060 | M22 and ResurFx Systems | Lumenis, Ltd. | 2017-08-09 | Special | PDF ↗ |
| K172096 | Fraxis | Ilooda Co,., Ltd. | 2017-08-09 | Special | PDF ↗ |
| K170738 | InMode Diolaze XL | Inmode MD , Ltd. | 2017-08-07 | Traditional | PDF ↗ |
| K171079 | Q-Switched Nd:YAG Laser System | Ids, Ltd. | 2017-08-01 | Traditional | PDF ↗ |
| K172025 | Litho 60 | Quanta System Spa | 2017-07-31 | Special | PDF ↗ |
| K171945 | Discovery Pico, Discovery Pico Plus | Quanta System Spa | 2017-07-28 | Traditional | PDF ↗ |
| K170187 | Photodynamic Therapy Device | Uvbiotek, LLC | 2017-07-28 | Traditional | PDF ↗ |
| K171255 | Monteris Medical NeuroBlate System | Monteris Medical, Inc. | 2017-07-25 | Traditional | PDF ↗ |
| K170073 | LightMed Dental Laser System | Lightmed Dentaltechnology Corp. | 2017-07-25 | Traditional | PDF ↗ |
| K171711 | Thunder, Thunder VT, Thunder HR | Quanta System Spa | 2017-07-07 | Special | PDF ↗ |
| K171009 | LASEMD Laser System | Lutronic Corporation | 2017-06-23 | Traditional | PDF ↗ |
| K163449 | HyPHo Laser System | Hyper Photonics Srl | 2017-06-23 | Traditional | PDF ↗ |
| K162886 | DEKA MOTUS AX | El.En Electronic Engineering Spa | 2017-06-19 | Traditional | PDF ↗ |
| K162659 | Diode Laser Hair Removal System | Shandong Huamei Technology Co., Ltd. | 2017-06-16 | Traditional | PDF ↗ |
| K170850 | Alma Q | Alma Lasers , Ltd. | 2017-06-15 | Traditional | PDF ↗ |
| K162755 | Picocare | Wontech Co., Ltd. | 2017-06-12 | Traditional | PDF ↗ |
| K170366 | Laser Peripherals, LLC Family of Bare Laser Fibers | Laser Peripherals, LLC | 2017-06-08 | Traditional | PDF ↗ |
| K170626 | Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform, Soprano YAG Hand piece | Alma Lasers, Inc. | 2017-05-31 | Traditional | PDF ↗ |
| K170597 | PicoWay Laser System | Syneron Candela Corporation | 2017-05-25 | Traditional | PDF ↗ |
| K163196 | ACTION II Laser System | Lutronic Corporation | 2017-05-24 | Traditional | PDF ↗ |
| K163197 | Cook Holmium Laser Fiber | Cook Incorporated | 2017-05-24 | Traditional | PDF ↗ |
| K170121 | Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories | Lumenis, Ltd. | 2017-05-22 | Special | PDF ↗ |
| K160677 | MICRORUPTOR 6 | Meridian AG | 2017-05-19 | Traditional | PDF ↗ |
| K170500 | SIROLaser Advance+ | Dentsply Sirona | 2017-05-16 | Traditional | PDF ↗ |
| K163638 | Dental 5 Multi Diode laser | Bio-Med USA, Inc. | 2017-05-15 | Traditional | PDF ↗ |
| K170734 | Venus Silk.expert | Cyden Limited | 2017-05-08 | Special | PDF ↗ |
| K170718 | Iridex TruFocus LIO Premiere | Iridex Corporation | 2017-05-03 | Traditional | PDF ↗ |
| K162334 | U.S. Laser Worx Patriot 1 family of lasers | U.S. Laser Worx | 2017-04-27 | Traditional | PDF ↗ |
| K170936 | Cutera enlighten III Laser System | Cutera, Inc. | 2017-04-25 | Special | PDF ↗ |
| K170215 | LaserDock, HolmiumDock, CO2Dock,OmniDock, KTPDock | Patient Pocket, LLC | 2017-04-19 | Traditional | PDF ↗ |
| K170724 | NeuroBlate System | Monteris Medical, | 2017-04-07 | Special | PDF ↗ |
| K160549 | MEDICAL DIODE LASER SYSTEMS | Wuhan Gigaa Optronics Technology Co., Ltd. | 2017-04-07 | Traditional | PDF ↗ |
| K161257 | MultiPulse HoPLUS | Asclepion Laser Technologies GmbH | 2017-03-31 | Special | PDF ↗ |
| K162556 | LIGHTFUSION LED SYSTEM | Vitage Led, Ltd. | 2017-03-24 | Traditional | PDF ↗ |
| K163103 | Tranberg CLS Diffusor Laser Fiber | Clinical Laserthermia Systems, AB | 2017-03-23 | Special | PDF ↗ |
| K163655 | Sparkling | Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd | 2017-03-17 | Traditional | PDF ↗ |
| K170331 | Cyber Ho | Quanta System Spa | 2017-03-03 | Special | PDF ↗ |
| K162837 | Smart Laser Indirect Ophthalmoscope (LIO); Laser delivery device for Lumenis Novus Spectra Laser System, Lumenis Vision One Laser System, and Lumenis Smart532 Laser System | Lumenis, Ltd. | 2017-02-28 | Traditional | PDF ↗ |
| K161926 | ND YAG Q-switch Laser Therapy Machine | Beijing Adss Development Co., Ltd. | 2017-02-22 | Traditional | PDF ↗ |
| K163123 | Q-Switched Nd:YAG Laser Therapy Systems | Beijing Sincoheren Science and Technology Development Co. | 2017-02-02 | Traditional | PDF ↗ |
| K162454 | PicoWay Laser System | Syneron Candela Corporation | 2017-02-01 | Traditional | PDF ↗ |
| K162851 | eLyx-PRO | Intelligent Sensory Concept SA | 2017-01-24 | Traditional | PDF ↗ |
| K162765 | Venus Velocity Diode Laser System | Venus Concept , Ltd. | 2017-01-11 | Traditional | PDF ↗ |
| K163128 | Epic Pro | Biolase, Inc. | 2017-01-11 | Special | PDF ↗ |
| K162114 | Photon, Photon Plus | Zolar Technology & Mfg Co., Inc. | 2016-12-12 | Traditional | PDF ↗ |
| K161632 | FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag) | Bios S.R.L. | 2016-12-08 | Traditional | PDF ↗ |
| K163222 | Discovery Pico Family | Quanta System Spa | 2016-12-05 | Special | PDF ↗ |
| K163009 | Litho | Quanta System Spa | 2016-12-01 | Special | PDF ↗ |
| K162191 | NAVILAS Laser System | Od-Os GmbH | 2016-11-22 | Traditional | PDF ↗ |
| K162363 | V30 system, V-Form Handpiece BC Medium applicator | Viora , Ltd. | 2016-11-18 | Traditional | PDF ↗ |
| K161692 | Diode Laser Therapy Machine | Beijing Adss Development Co., Ltd. | 2016-11-16 | Traditional | PDF ↗ |
Product code GEX · Class II · General, Plastic Surgery. Data: openFDA.