Panels › General, Plastic Surgery › Product code GEX · Class 2
Powered Laser Surgical Instrument
Regulation 878.4810
69510(k)s in 12 months (2,892 all time)
6recalls in 12 months (201 all time)
150recalls that name a 510(k)
Top companies in GEX
| Company | 510(k)s | Recalls |
|---|---|---|
| Cynosure, Inc. | 84 | 1 |
| Lumenis | 60 | 11 |
| Sharplan Lasers, Inc. | 66 | 0 |
| Quanta System Spa | 57 | 6 |
| Candela Corp. | 53 | 5 |
| Laserscope | 49 | 0 |
| Trimedyne, Inc. | 48 | 0 |
| Heraeus Lasersonics, Inc. | 37 | 0 |
| Surgical Laser Technologies, Inc. | 35 | 0 |
| Boston Scientific | 11 | 23 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 8, 2017 | K171648 | BM.IRIS Bluecore Co., Ltd., KR | GEX |
| Sep 1, 2017 | K170970 | Epilaser Epilady 2000, LLC, IL | GEX |
| Aug 24, 2017 | K171921 | VenaCure EVLT NeverTouch Procedure Kit AngioDynamics, Inc. | GEX |
| Aug 18, 2017 | K171227 | StarWalker Fotona D.O.O., SI | GEX |
| Aug 9, 2017 | K172096 | Fraxis Ilooda Co,., Ltd., KR | GEX |
| Aug 9, 2017 | K170060 | M22 and ResurFx Systems Lumenis, Ltd., IL | GEX |
| Aug 7, 2017 | K170738 | InMode Diolaze XL Inmode MD , Ltd., IL | GEX |
| Aug 1, 2017 | K171079 | Q-Switched Nd:YAG Laser System Ids, Ltd., KR | GEX |
| Jul 31, 2017 | K172025 | Litho 60 Quanta System Spa, IT | GEX |
| Jul 28, 2017 | K171945 | Discovery Pico, Discovery Pico Plus Quanta System Spa, IT | GEX |
| Jul 28, 2017 | K170187 | Photodynamic Therapy Device Uvbiotek, LLC | GEX |
| Jul 25, 2017 | K171255 | Monteris Medical NeuroBlate System Monteris Medical, Inc. | GEX |
| Jul 25, 2017 | K170073 | LightMed Dental Laser System Lightmed Dentaltechnology Corp., TW | GEX |
| Jul 7, 2017 | K171711 | Thunder, Thunder VT, Thunder HR Quanta System Spa, IT | GEX |
| Jun 23, 2017 | K171009 | LASEMD Laser System Lutronic Corporation, KR | GEX |
| Jun 23, 2017 | K163449 | HyPHo Laser System Hyper Photonics Srl, IT | GEX |
| Jun 19, 2017 | K162886 | DEKA MOTUS AX El.En Electronic Engineering Spa, IT | GEX |
| Jun 16, 2017 | K162659 | Diode Laser Hair Removal System Shandong Huamei Technology Co., Ltd., CN | GEX |
| Jun 15, 2017 | K170850 | Alma Q Alma Lasers , Ltd., IL | GEX |
| Jun 12, 2017 | K162755 | Picocare Wontech Co., Ltd., KR | GEX |
| Jun 8, 2017 | K170366 | Laser Peripherals, LLC Family of Bare Laser Fibers Laser Peripherals, LLC | GEX |
| May 31, 2017 | K170626 | Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform, Soprano YAG Hand piece Alma Lasers, Inc. | GEX |
| May 25, 2017 | K170597 | PicoWay Laser System Syneron Candela Corporation | GEX |
| May 24, 2017 | K163197 | Cook Holmium Laser Fiber Cook Incorporated | GEX |
| May 24, 2017 | K163196 | ACTION II Laser System Lutronic Corporation, KR | GEX |
| May 22, 2017 | K170121 | Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories Lumenis, Ltd., IL | GEX |
| May 19, 2017 | K160677 | MICRORUPTOR 6 Meridian AG, CH | GEX |
| May 16, 2017 | K170500 | SIROLaser Advance+ Dentsply Sirona | GEX |
| May 15, 2017 | K163638 | Dental 5 Multi Diode laser Bio-Med USA, Inc. | GEX |
| May 8, 2017 | K170734 | Venus Silk.expert Cyden Limited, GB | GEX |
| May 3, 2017 | K170718 | Iridex TruFocus LIO Premiere Iridex Corporation | GEX |
| Apr 27, 2017 | K162334 | U.S. Laser Worx Patriot 1 family of lasers U.S. Laser Worx | GEX |
| Apr 25, 2017 | K170936 | Cutera enlighten III Laser System Cutera, Inc. | GEX |
| Apr 19, 2017 | K170215 | LaserDock, HolmiumDock, CO2Dock,OmniDock, KTPDock Patient Pocket, LLC | GEX |
| Apr 7, 2017 | K170724 | NeuroBlate System Monteris Medical, | GEX |
| Apr 7, 2017 | K160549 | MEDICAL DIODE LASER SYSTEMS Wuhan Gigaa Optronics Technology Co., Ltd., CN | GEX |
| Mar 31, 2017 | K161257 | MultiPulse HoPLUS Asclepion Laser Technologies GmbH, DE | GEX |
| Mar 24, 2017 | K162556 | LIGHTFUSION LED SYSTEM Vitage Led, Ltd., GB | GEX |
| Mar 23, 2017 | K163103 | Tranberg CLS Diffusor Laser Fiber Clinical Laserthermia Systems, AB, SE | GEX |
| Mar 17, 2017 | K163655 | Sparkling Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd, CN | GEX |
| Mar 3, 2017 | K170331 | Cyber Ho Quanta System Spa, IT | GEX |
| Feb 28, 2017 | K162837 | Smart Laser Indirect Ophthalmoscope (LIO); Laser delivery device for Lumenis Novus Spectra Laser System, Lumenis Vision Lumenis, Ltd., IL | GEX |
| Feb 22, 2017 | K161926 | ND YAG Q-switch Laser Therapy Machine Beijing Adss Development Co., Ltd., CN | GEX |
| Feb 2, 2017 | K163123 | Q-Switched Nd:YAG Laser Therapy Systems Beijing Sincoheren Science and Technology Development Co., CN | GEX |
| Feb 1, 2017 | K162454 | PicoWay Laser System Syneron Candela Corporation | GEX |
| Jan 24, 2017 | K162851 | eLyx-PRO Intelligent Sensory Concept SA, CH | GEX |
| Jan 11, 2017 | K163128 | Epic Pro Biolase, Inc. | GEX |
| Jan 11, 2017 | K162765 | Venus Velocity Diode Laser System Venus Concept , Ltd. | GEX |
| Dec 12, 2016 | K162114 | Photon, Photon Plus Zolar Technology & Mfg Co., Inc., CA | GEX |
| Dec 8, 2016 | K161632 | FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag) Bios S.R.L., IT | GEX |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.