Panels › General, Plastic Surgery › Product code GEX · Class 2
Powered Laser Surgical Instrument
Regulation 878.4810
71510(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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2013 | Lumenis, Inc. Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053.
Intended for use in the treatment of ocular pathology. Terminated |
GEX | K111213 |
| Jun 26, 2013 | ConBio, a CynoSure Company Multilite Dye Handpieces, an optional accessory of the RevLite SI Laser.
The Revlite SI laser is intended for General Dermatology, Dermatologic and General Surgical Procedures. Which includes treatme Terminated |
GEX | K103118 |
| May 25, 2013 | Angiodynamics, Inc. AngioDynamics VenaCure EVLT NeverTouch-FRS PROCEDURE KIT under the following labeling:
1) Gold-Tipped Fiber 45cm Kit, Catalog Number: 11403301; 2) Gold-Tipped Fiber 65cm Kit, Catalog Number: 114033 Terminated |
GEX | K102796 |
| Apr 29, 2013 | Discus Dental LLC SL3 SOFT-TISSUE Laser (Model LR2002); Manuf: Discus Dental, LLC, 8550 Higuera Street, Culver City CA 90232.
The SL3 is a soft-tissue diode laser intended to be used for dental procedures Terminated |
GEX | K102639 |
| Jan 22, 2013 | AMS Innovative Center - San Jose GreenLight HPS (High Performance System)
GreenLight XPS (Xcelerated Performance System)
Manufactured by AMS, Solutions for Life
Innovation Center.
GreenLight HPS and XPS Surgical Lasers Systems and Terminated |
GEX | K062719 K092735 |
| Jan 17, 2013 | Quanta System, S.p.A. Ultrawave II EX 1320/ Ultrawave III EX 1320 Powered Laser Surgical Instrument.
Nd:YAG 1064 nm: Coagulation and hemostasis of benign vascular lesions (e.g. port wine stains, hemangiomas, warts, telangi Terminated |
GEX | K070805 K083207 |
| Jan 17, 2013 | Quanta System, S.p.A. Eterna Giovinezza System, Powered Laser Surgical Instrument.
Permanent hair reduction; Photocoagulation of dermatological vascular lesions; Photothermolysis of blood vessels (treatment of facial and Terminated |
GEX | K051113 |
| Jan 17, 2013 | Quanta System, S.p.A. Q-Plus T Powered Laser Surgical Instrument
Nd:YAG 1064 nm and 532 nm: Treatment of vascular lesions and pigmented lesions; Hair and tattoo removal; The incision, excision, ablation, vaporization of s Terminated |
GEX | K073549 K123168 |
| Dec 3, 2012 | OmniGuide, Inc. OmniGuide BP-ROBOTIC ( BeamPath Robotic), Single Use
Cat. # BP-ROBOTIC
The OmniGuide Fiber is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues includi Terminated |
GEX | K070157 |
| Mar 29, 2012 | Aerolase Aerolase Corporation. The products involved are the FriendlyLight YAG lasers, a Model Family first identified and reported.
The products are marketed under names including FriendlyLight Er:YAG, Ligh Terminated |
GEX | None listed |
| Jan 13, 2012 | Angiodynamics Worldwide Headquarters VenaCureEVLT Perforator Vein Ablation Kit, CATALOG #: EVLT/PVAK, STERILE -- Manufactured for: AngioDynamics Inc. 603 Queensbury, NY 12804 USA, AngioDynamics UK Limited, Building 2000, Beach Drive, IQ Terminated |
GEX | None listed |
| Jan 11, 2012 | Angiodynamics Worldwide Headquarters VenaCure EVLT NeverTouch-FRS PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 cm, VC NT FRS 65cm Clear Non-Echo Needle, Catalog No./REF 51403005, STERILE -- AngioDynamics, Inc. 603 Queensbury, NY USA 12 Terminated |
GEX | K102796 |
| Jan 11, 2012 | Angiodynamics Worldwide Headquarters VenaCure EVLT NeverTouch-FRS PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 cm, VenaCure NeverTouch FRS 65cm Clear Needle, Catalog No./REF 51403002, STERILE -- AngioDynamics, Inc. 603 Queensbury, NY U Terminated |
GEX | K102796 |
| Jan 11, 2012 | Angiodynamics Worldwide Headquarters VenaCure EVLT NeverTouch-FRS PROCEDURE KIT Featuring Gold-Tipped Fiber, 45 cm, VenaCure NeverTouch FRS 45cm Clear Needle, Catalog No./REF 51403001, STERILE -- AngioDynamics, Inc. 603 Queensbury, NY US Terminated |
GEX | K102796 |
| Jan 11, 2012 | Angiodynamics Worldwide Headquarters VenaCure EVLT NeverTouch PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 cm, NeverTouch Procedure Kit 65cm, Catalog No./REF 51402008, STERILE -- AngioDynamics, Inc. 603 Queensbury, NY USA 12804. This i Terminated |
GEX | K102796 |
| Jan 11, 2012 | Angiodynamics Worldwide Headquarters VenaCure EVLT NeverTouch PROCEDURE KIT Featuring Gold-Tipped Fiber, 45 cm, NeverTouch Procedure Kit 45cm, Catalog No./REF 51402007, STERILE -- AngioDynamics, Inc. 603 Queensbury, NY USA 12804. This i Terminated |
GEX | K102796 |
| Jan 11, 2012 | Angiodynamics Worldwide Headquarters VenaCure EVLT NeverTouch - FRS .018 " System PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 cm, 65cm NeverTouch FRS .018 Procedure Kit, Catalog No./REF 11403013, STERILE -- AngioDynamics, Inc. 603 Quee Terminated |
GEX | K102796 |
| Jan 11, 2012 | Angiodynamics Worldwide Headquarters VenaCure EVLT NeverTouch - FRS .018 " System PROCEDURE KIT Featuring Gold-Tipped Fiber, 45 cm, 45cm NeverTouch FRS .018 Procedure Kit, Catalog No./REF 11403012, STERILE -- AngioDynamics, Inc. 603 Quee Terminated |
GEX | K102796 |
| Jan 11, 2012 | Angiodynamics Worldwide Headquarters VenaCure EVLT NeverTouch - FRS w/19 ga Needle PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 cm, NT FRS 65cm Kit w/19Ga Needle, Catalog No./REF 11403006, STERILE -- AngioDynamics, Inc. 603 Queensbury, Terminated |
GEX | K102796 |
| Jan 11, 2012 | Angiodynamics Worldwide Headquarters VenaCure EVLT NeverTouch - FRS w/19 ga Needle PROCEDURE KIT Featuring Gold-Tipped Fiber, 45 cm, NT FRS 45cm Kit w/19Ga Needle, Catalog No./REF 11403005, STERILE -- AngioDynamics, Inc. 603 Queensbury, Terminated |
GEX | K102796 |
| Jan 11, 2012 | Angiodynamics Worldwide Headquarters VenaCure EVLT NeverTouch - FRS PROCEDURE KIT Featuring Gold-Tipped Fiber, 90 cm, VC EVLT NeverTouch-FRS 90cm Kit, Catalog No./REF 11403004, STERILE -- AngioDynamics, Inc. 603 Queensbury, NY USA 12804 Terminated |
GEX | K102796 |
| Jan 11, 2012 | Angiodynamics Worldwide Headquarters VenaCure EVLT NeverTouch - FRS .018" System PROCEDURE KIT Featuring Gold-Tipped Fiber, 25 cm, VC EVLT NeverTouch-FRS 0.18 25 cm Kit, Catalog No./REF 11403003, STERILE -- AngioDynamics, Inc. 603 Queens Terminated |
GEX | K102796 |
| Jan 11, 2012 | Angiodynamics Worldwide Headquarters VenaCure EVLT NeverTouch - FRS PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 cm, NeverTouch 65cm Kit w/Gripper and RFID T, Catalog No./REF 11403002, STERILE -- AngioDynamics, Inc. 603 Queensbury, NY U Terminated |
GEX | K102796 |
| Jan 11, 2012 | Angiodynamics Worldwide Headquarters VenaCure EVLT NeverTouch - FRS PROCEDURE KIT Featuring Gold-Tipped Fiber, 45 cm, NeverTouch 45cm Kit w/Gripper and RFID T, Catalog No./REF 11403001, STERILE -- AngioDynamics, Inc. 603 Queensbury, NY Terminated |
GEX | K102796 |
| Jan 11, 2012 | Angiodynamics Worldwide Headquarters VenaCure EVLT NeverTouch PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 cm, NeverTouch Kit 65CM Internal Sheath, Catalog No./REF 11402002, STERILE -- AngioDynamics, Inc. 603 Queensbury, NY USA 12804.
Terminated |
GEX | K102796 |
| Jan 11, 2012 | Angiodynamics Worldwide Headquarters VenaCure EVLT NeverTouch PROCEDURE KIT Featuring Gold-Tipped Fiber, 45 cm, NeverTouch Kit 45CM Internal Sheath, Catalog No./REF 11402001, STERILE -- AngioDynamics, Inc. 603 Queensbury, NY USA 12804. Terminated |
GEX | K102796 |
| Mar 3, 2011 | Vascular Solutions, Inc. Vari Lase WireFiber Laser Fiber, RED 7137, Rx ONLY, Sterile EO, Vascular Solutions Inc., 6464 Sycamore Court, Minneapolis, MN 55369
The VARI-LASE WireFiber is indicated for the treatment of varicose Terminated |
GEX | K072332 |
| Feb 14, 2011 | AMS Innovative Center - San Jose AMS brand GreenLight PV Laser System, Model-P/N: 0010-9230;
Product is manufactured and distributed by AMS Solutions,
San Jose, CA
The GreenLight Surgical Laser System and accessories are intended for Terminated |
GEX | K010284 |
| Dec 29, 2010 | AMS Innovative Center - San Jose GreenLight MoXy Fiber Optic, part number 0010-2400, for use with the GreenLight XPS Laser System, manufactured by American Medical Systems Inc., San Jose, CA
The XPS Laser system is indicated for surg Terminated |
GEX | K100746 |
| Sep 25, 2010 | AMS Innovative Center - San Jose GreenLight HPS fiber optics, Model Number 10-2090, manufactured by AMS (American Medical Systems), San Jose, CA. Potentially Mislabeled as GreenLight PV 10-2079 Terminated |
GEX | K062719 |
| Sep 10, 2010 | AMD Lasers, LLC Picasso/Picasso Lite lasers
Intended use: Dentistry. Terminated |
GEX | None listed |
| Sep 3, 2009 | Sybaritic, Inc Sybaritic, NannoLight MP50.
Model Numbers and Description:
1.) 304207-MP 220 Volt, Multi-Platform configuration (able to attach optional
laser handpiece when purchas Terminated |
GEX | K082033 |
| Jan 13, 2009 | Sterilmed Inc Laser Probe Model #': SYN55.26.25
Reprocessed laser probes are part of a laser delivery system and are used in opthalmic procedures where laser energy is the mode of treatment. Terminated |
GEX | K012682 |
| Apr 9, 2008 | Lumenis, Inc. Boston Scientific SlimLine 200 Micron Holmium Fiber Delivery Device, Catalog No. 840-840, Sterile, Made In Israel, Manufactured By LUMENIS, P.O.Box 240, Yokneam, ISRAEL. Terminated |
GEX | K011703 |
| Mar 20, 2008 | AMS Innovative Center - San Jose GreenLight HPS System, Surgical Laser System and Accessories. Part Numbers 0010-0070 and 0010-0075 (international units), AMS Innovative Center, San Jose, CA 95134. Terminated |
GEX | K010284 K062719 |
| Feb 26, 2008 | AMS Innovative Center - San Jose American Medical Systems, Inc., (AMS) GreenLight HPS Fiber Optic (ADDStat) Part Number 0010-2090B. Fiber optic laser for treatment of BPH (Benign Prostatic Hyperplasia). AMS Innovative Center, San J Terminated |
GEX | K010284 K062719 |
| Feb 15, 2007 | Candela Laser Corporation Candela Corporation Vbeam Perfecta Laser System, Model/Catalog # 9914-08-0300 Vbeam Perfecta w/ gray enclosure and gray colored display Terminated |
GEX | None listed |
| Feb 15, 2007 | Candela Laser Corporation Candela Corporation Vbeam Perfecta Laser System, Model/Catalog # 9914-00-0300 Vbeam Perfecta w/ rose/gray enclosure and rose colored display Terminated |
GEX | None listed |
| Feb 15, 2007 | Candela Laser Corporation Candela Corporation Vbeam Platinum Laser System, Model/Catalog # 9914-08-0310 Vbeam Platinum w/ gray enclosure and gray colored display Terminated |
GEX | None listed |
| Feb 15, 2007 | Candela Laser Corporation Candela Corporation Vbeam Platinum Laser System, Model/Catalog # 9914-00-0310 Vbeam Platinum w/ rose gray enclosure and rose colored display Terminated |
GEX | None listed |
| Feb 15, 2007 | Candela Laser Corporation Candela Corporation Vbeam Aesthetica Laser System, Model/Catalog # 9914-08-0320 Vbeam Aesthetica w/ gray enclosure and gray display Terminated |
GEX | None listed |
| Feb 15, 2007 | Candela Laser Corporation Candela Corporation Vbeam Aesthetica Laser System, Model/Catalog # 9914-00-0320 Vbeam Aesthetica w/ gray enclosure and rose colored display Terminated |
GEX | K050673 |
| Oct 12, 2006 | Lumenis Inc. Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue.
Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA Terminated |
GEX | K011703 |
| Mar 2, 2006 | Lumenis Inc. Lumenis brand Atlas, Corium, Elite, Elite Ultra 532nm Laser Systems;
Manufactured before November 4, 2003;
Manufactured by Lumenis, Inc., 3959 West 1820 South, Salt Lake City, Utah 84104 Terminated |
GEX | K913569 K990179 |
| Feb 23, 2006 | Lumenis Inc. Lumenis brand LightSheer Pulsed Diode Array Laser System; All serial numbers;
Manufactured by RH USA, Inc., 201 Lindbergh Avenue, Livermore, California 94551 Terminated |
GEX | K003614 |
| Feb 16, 2006 | Lumenis Inc. Lumenis brand Lumenis One System with Multi-Spot Nd:YAG, LightSheer and Universal IPL; Manufactured by Lumenis, Ltd, 13 Hayetzira Street, Yokneam Industrial Park, Yokneam, Israel 20692 Terminated |
GEX | K030342 |
| Jul 20, 2004 | Carl Zeiss Ophthalmic Systems Inc Surgical powered laser instrument, used for photocoagulation of ocular tissues in the treatment of diseases of the eye. Terminated |
GEX | K013402 |
| Jan 1, 2004 | Candela Laser Corporation Candela Smoothbeam Laser System
Model Numbers: 9914-00-0820
9914-06-0820
9914-07-0820
9914-08-0820
Terminated |
GEX | K013825 K022884 +2 |
| Nov 6, 2003 | Vascular Solutions, Inc Vari-Lase Endovenous Laser Procedural Kit, Model 7000 Terminated |
GEX | K030654 |
| Aug 12, 2003 | Intralase Corp Intralase FS Laser System.
Laser Keratome Terminated |
GEX | K001211 K002890 +2 |
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