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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)
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Top companies in GEX

DateFirm and productCodeLinked 510(k)
Sep 11, 2013Lumenis, Inc.
Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use in the treatment of ocular pathology.
Terminated
GEXK111213
Jun 26, 2013ConBio, 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
GEXK103118
May 25, 2013Angiodynamics, 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
GEXK102796
Apr 29, 2013Discus 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
GEXK102639
Jan 22, 2013AMS 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
GEXK062719
K092735
Jan 17, 2013Quanta 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
GEXK070805
K083207
Jan 17, 2013Quanta 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
GEXK051113
Jan 17, 2013Quanta 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
GEXK073549
K123168
Dec 3, 2012OmniGuide, 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
GEXK070157
Mar 29, 2012Aerolase
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
GEXNone listed
Jan 13, 2012Angiodynamics 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
GEXNone listed
Jan 11, 2012Angiodynamics 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
GEXK102796
Jan 11, 2012Angiodynamics 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
GEXK102796
Jan 11, 2012Angiodynamics 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
GEXK102796
Jan 11, 2012Angiodynamics 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
GEXK102796
Jan 11, 2012Angiodynamics 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
GEXK102796
Jan 11, 2012Angiodynamics 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
GEXK102796
Jan 11, 2012Angiodynamics 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
GEXK102796
Jan 11, 2012Angiodynamics 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
GEXK102796
Jan 11, 2012Angiodynamics 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
GEXK102796
Jan 11, 2012Angiodynamics 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
GEXK102796
Jan 11, 2012Angiodynamics 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
GEXK102796
Jan 11, 2012Angiodynamics 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
GEXK102796
Jan 11, 2012Angiodynamics 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
GEXK102796
Jan 11, 2012Angiodynamics 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
GEXK102796
Jan 11, 2012Angiodynamics 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
GEXK102796
Mar 3, 2011Vascular 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
GEXK072332
Feb 14, 2011AMS 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
GEXK010284
Dec 29, 2010AMS 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
GEXK100746
Sep 25, 2010AMS 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
GEXK062719
Sep 10, 2010AMD Lasers, LLC
Picasso/Picasso Lite lasers Intended use: Dentistry.
Terminated
GEXNone listed
Sep 3, 2009Sybaritic, 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
GEXK082033
Jan 13, 2009Sterilmed 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
GEXK012682
Apr 9, 2008Lumenis, 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
GEXK011703
Mar 20, 2008AMS 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
GEXK010284
K062719
Feb 26, 2008AMS 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
GEXK010284
K062719
Feb 15, 2007Candela Laser Corporation
Candela Corporation Vbeam Perfecta Laser System, Model/Catalog # 9914-08-0300 Vbeam Perfecta w/ gray enclosure and gray colored display
Terminated
GEXNone listed
Feb 15, 2007Candela Laser Corporation
Candela Corporation Vbeam Perfecta Laser System, Model/Catalog # 9914-00-0300 Vbeam Perfecta w/ rose/gray enclosure and rose colored display
Terminated
GEXNone listed
Feb 15, 2007Candela Laser Corporation
Candela Corporation Vbeam Platinum Laser System, Model/Catalog # 9914-08-0310 Vbeam Platinum w/ gray enclosure and gray colored display
Terminated
GEXNone listed
Feb 15, 2007Candela Laser Corporation
Candela Corporation Vbeam Platinum Laser System, Model/Catalog # 9914-00-0310 Vbeam Platinum w/ rose gray enclosure and rose colored display
Terminated
GEXNone listed
Feb 15, 2007Candela Laser Corporation
Candela Corporation Vbeam Aesthetica Laser System, Model/Catalog # 9914-08-0320 Vbeam Aesthetica w/ gray enclosure and gray display
Terminated
GEXNone listed
Feb 15, 2007Candela Laser Corporation
Candela Corporation Vbeam Aesthetica Laser System, Model/Catalog # 9914-00-0320 Vbeam Aesthetica w/ gray enclosure and rose colored display
Terminated
GEXK050673
Oct 12, 2006Lumenis 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
GEXK011703
Mar 2, 2006Lumenis 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
GEXK913569
K990179
Feb 23, 2006Lumenis Inc.
Lumenis brand LightSheer Pulsed Diode Array Laser System; All serial numbers; Manufactured by RH USA, Inc., 201 Lindbergh Avenue, Livermore, California 94551
Terminated
GEXK003614
Feb 16, 2006Lumenis 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
GEXK030342
Jul 20, 2004Carl Zeiss Ophthalmic Systems Inc
Surgical powered laser instrument, used for photocoagulation of ocular tissues in the treatment of diseases of the eye.
Terminated
GEXK013402
Jan 1, 2004Candela Laser Corporation
Candela Smoothbeam Laser System Model Numbers: 9914-00-0820 9914-06-0820 9914-07-0820 9914-08-0820
Terminated
GEXK013825
K022884 +2
Nov 6, 2003Vascular Solutions, Inc
Vari-Lase Endovenous Laser Procedural Kit, Model 7000
Terminated
GEXK030654
Aug 12, 2003Intralase Corp
Intralase FS Laser System. Laser Keratome
Terminated
GEXK001211
K002890 +2

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