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Panels › General, Plastic Surgery › Product code GEX · Class 2

Powered Laser Surgical Instrument

Regulation 878.4810

72510(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)
Oct 24, 2019Candela Corporation
Canister HFC-134a /1000g, ALUM, 15 pack Product Number: 1600-00-0219 Revision .0C Coolant canister for use with surgical laser.
Terminated
GEXNone listed
Oct 24, 2019Candela Corporation
Canister HFC-134a /1000g, ALUM Product Number: 1600-00-0218 Revision .0C Coolant canister for use with surgical laser.
Terminated
GEXNone listed
Oct 18, 2019Xintec Corp
OptiLITE, Products for Laser Surgery, Model # CGH1080F, 800 micron single-use holmium fiber assembly with flat tip, Lot Number 21144, Sterilized by Sterrad Run 4149, This device is for single-use only
Terminated
GEXK992866
Aug 1, 2019Aerolase Corporation
LightPod Neo Lasers
Terminated
GEXNone listed
Aug 1, 2019Aerolase Corporation
LightPod ERA lasers
Terminated
GEXNone listed
Jul 8, 2019Medtronic Navigation, Inc.
Visualase Cooled Laser Applicator System Tubing Set kits Product numbers: VCLAS 9735559, 3mm tip/1.65mm catheter VCLAS 9735560, 10mm tip/1.65mm catheter VCLAS 9735561, 15mm tip/1.85mm catheter
Terminated
GEXK071328
Jun 27, 2019Angiodynamics, Inc.
AngioDynamics VenaCure EVLT NeverTouch Procedure Kit, 45CM NEVERTOUCH FRS .018 PROCEDURE KIT PG, Catalog Number 11403012
Terminated
GEXK112600
May 22, 2019Boston Scientific Corporation
AURIGA 30 GENERAL ZERO COST SYSTEM UPN: M0068S30GZ0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in
Terminated
GEXK111475
May 22, 2019Boston Scientific Corporation
AURIGA 30 GENERAL - DEMO SYSTEM UPN: M0068S30GD0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in su
Terminated
GEXK111475
May 22, 2019Boston Scientific Corporation
AURIGA 30 GENERAL SYSTEM UPN: M0068S30G0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical pr
Terminated
GEXK111475
May 22, 2019Boston Scientific Corporation
AURIGA 30 BRAZIL ZERO COST SYSTEM UPN: M0068S30BZ0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in s
Terminated
GEXK111475
May 22, 2019Boston Scientific Corporation
AURIGA 30 BRAZIL SYSTEM UPN: M0068S30B0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical pro
Terminated
GEXK111475
May 22, 2019Boston Scientific Corporation
AURIGA XL 4007 GENERAL - ZERO COST SYSTE UPN: FS4007GZ0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used
Terminated
GEXK111475
May 22, 2019Boston Scientific Corporation
AURIGA XL 4007 GENERAL - DEMO SYSTEM UPN: M0068FS4007GD0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be use
Terminated
GEXK111475
May 22, 2019Boston Scientific Corporation
AURIGA XL 4007 GENERAL SYSTEM UPN: M0068FS4007G0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in sur
Terminated
GEXK111475
May 22, 2019Boston Scientific Corporation
AURIGA XL 4007 BRAZIL SYSTEM Model: M0068FS4007B0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in s
Terminated
GEXK111475
Apr 1, 2019Dornier Medtech America, Inc.
Dornier Diode Laser Fibers:Used with Dornier Medilas D Family Lasers Part Number/Description: K1001291 600 micron single use fiber K2011824 600 micron single use fiber K1001293 600 micron single use f
Terminated
GEXK083500
Oct 17, 2018Leoni Fiber Optics GmbH
Laser Fiber Assy-Single Use-LFS-200-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-ForTec Fiber SU-200-TRUE-RT Label Smartscope packaging. The Laser peripherals bare laser fibers, ENT fibers an
Terminated
GEXK050738
Oct 17, 2018Leoni Fiber Optics GmbH
Laser Fiber Assy-Single Use-LFS-940-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-Private label: SU-1000-RT SmartScope Packaging. The Laser peripherals bare laser fibers, ENT fibers and Endo
Terminated
GEXK050738
Oct 17, 2018Leoni Fiber Optics GmbH
Laser Fiber Assy-Single Use-LFS-550-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-Private label: SU-550-RT SmartScope Packaging. The Laser peripherals bare laser fibers, ENT fibers and Endop
Terminated
GEXK050738
Oct 17, 2018Leoni Fiber Optics GmbH
Laser Fiber Assy-Single Use-LFS-365-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO- Private label: SU-365-RT SmartScope Packaging. The Laser peripherals bare laser fibers, ENT fibers and Endo
Terminated
GEXK050738
Oct 17, 2018Leoni Fiber Optics GmbH
Laser Fiber Assy-Single Use-LFS-272-RT-0.22NA-SMA905- Slim Extension Sleeve Silver-Sterile ETO- Private label: SU-200-RT SmartScope Packaging. The Laser peripherals bare laser fibers, ENT fibers and
Terminated
GEXK050738
Mar 23, 2018Medtronic Navigation, Inc.
Visualase Cooled Laser Applicator System (VCLAS) labeled as: a. Part Number 9735559, Visualase Cooled Laser Applicator System 3mm Tip; b. Part Number 9735560 Visualase Cooled Laser Applicator Sys
Terminated
GEXK053087
Mar 20, 2018Monteris Medical Corp
MONTERIS MEDICAL NEUROBLATE SYSTEM, used for MRI-guided neurosurgical ablation.
Terminated
GEXK171255
Mar 5, 2018Boston Scientific Corporation
Auriga XL 4007 Laser System, Universal Part Number: M0068FS4007G0. Intended to be used in surgical procedures.
Terminated
GEXK111475
Mar 5, 2018Boston Scientific Corporation
Auriga 30 Laser System, Universal Part Number: M0068S30G0. Intended to be used in surgical procedures.
Terminated
GEXK111475
Feb 27, 2018Iridex Corporation
Iridex TruFocus LIO Premiere" Laser Indirect Ophthalmoscope ( LIO ) The LIO is a headmounted indirect ophthalmoscope which is used with a handheld lens to view and perform laser treatments on a pat
Terminated
GEXK170718
Jul 27, 2017Medtronic Navigation, Inc.
VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part N
Terminated
GEXK053087
Jul 3, 2017Beijing Syntech Laser Co., Ltd
Beijing Syntech Laser UL Station surgical lasers
Open, Classified
GEXNone listed
Jul 3, 2017Beijing Syntech Laser Co., Ltd
Beijing Syntech Laser Nice Station Light Based Platform surgical lasers
Open, Classified
GEXNone listed
Jul 3, 2017Beijing Syntech Laser Co., Ltd
Beijing Syntech Laser APOLLO JV+ Medical Platform surgical lasers
Open, Classified
GEXNone listed
Jul 3, 2017Beijing Syntech Laser Co., Ltd
Beijing Syntech Laser APOLLO V+ Medical Platform surgical lasers
Open, Classified
GEXNone listed
Jul 3, 2017Beijing Syntech Laser Co., Ltd
Beijing Syntech Laser UL C02 Laser surgical lasers
Open, Classified
GEXNone listed
Jul 3, 2017Beijing Syntech Laser Co., Ltd
Beijing Syntech Laser Trixel 11 C02 Laser surgical lasers
Open, Classified
GEXNone listed
Jul 3, 2017Beijing Syntech Laser Co., Ltd
Beijing Syntech Laser Trixel C02 Laser surgical lasers
Open, Classified
GEXNone listed
Jul 3, 2017Beijing Syntech Laser Co., Ltd
Beijing Syntech Laser Diode Laser surgical lasers
Open, Classified
GEXNone listed
Jul 3, 2017Medtronic Navigation, Inc.
Medtronic Visualase(R) Cooled Laser Applicator System (VCLAS) 15MM TIP, REF 9735561, (1) Laser Diffusing Fiber - 600um Core, 15mm Tip, (1) Cooling Catheter with 3M(TM) SteriStrip(TM), (1) Pump Tubing
Terminated
GEXK053087
Jun 23, 2017Xintec Corp
OptiLITE(TM) Products for Laser Surgery, Catalog Numbers: HTM1020F, HTM1040F, HTM1060F, HTM1010F; Manufactured by CONVERGENT LASTER TECHNOLOGIES The Odyssey 30B is approved for numerous medical pr
Terminated
GEXK992866
Jun 6, 2017Laserex Systems Inc.
Ellex Tango Reflex with slit lamp Laser Ophthalmic In the SLT mode, the device is intended to be used for selective laser trabeculoplasty (ST) operations (laser trabeculoplasty for primary open an
Terminated
GEXNone listed
Jun 5, 2017Cook Inc.
Cook Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages
Terminated
GEXK124030
May 3, 2017Cook Inc.
OptiLite Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages Product Usage: Used with the Odyssey 30 Holmium Laser System for fragmentation of urinary c
Terminated
GEXK073496
Mar 27, 2017Strata Skin Sciences, Inc.
XTRAC Excimer Laser, Model No. AL8000, AL10000 The intended use is targeted UVB phototherapy for treatment of the skin conditions including psoriasis, vitiligo, atopic dermatitis, and leukoderma.
Terminated
GEXNone listed
Oct 23, 2016Lumenis Limited
FemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch" Tip (SPSA-20002590) Provide fractional treatments in gynecology.
Terminated
GEXK100415
Sep 19, 2016New Star Lasers, Inc.
ReNew (a.k.a. Trio) Dermatology: for use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue; for use in the treatment of fine lines and wrinkles; for trea
Terminated
GEXNone listed
Sep 19, 2016New Star Lasers, Inc.
VariaBreeze; Catalog number: 7300-0035-2. Podiatry: ablation, vaporization, incision, excision, and coagulation of soft tissue including matrixectomy, periungal and subungal warts, plantar warts, ra
Terminated
GEXK103338
Sep 19, 2016New Star Lasers, Inc.
CT3Plus (a.k.a. CT3PZ); Catalog number: 7300-0038/ 7300-0038-1. Dermatology: For use in dermatology for incision, excision, ablation, and vaporization with hemostasis of soft tissue; For treatment o
Terminated
GEXK101784
May 16, 2016Medtronic Navigation, Inc.
Visualase Cooled Laser Applicator System (VCLAS). The VCLAS system consists of the Visualase Laser Diffusing Fiber (LDF) and the Visualase Cooled Catheter System (CCS). The LDF and disposables (in
Terminated
GEXK053087
May 16, 2016Monteris Medical Corp
NeuroBlate System SideFire Select 2.2 mm Directional Laser Probe, Sterile EO. Model #s SFS000-01,SFS002-01, SFS122-01, SFS222-01, SFS322-01, SFS422-01, and SFS522-01. NeuroBlate System SideFire Sele
Terminated
GEXK143457
May 13, 2016Lumenis Ltd
Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-1014971).
Terminated
GEXK142860
May 5, 2016Ellipse A/S
Ellipse ND: YAG Laser applicator for Ellipse Nordlys system Medical Laser Products.
Terminated
GEXNone listed

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