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)
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) |
|---|---|---|---|
| Oct 24, 2019 | Candela Corporation Canister HFC-134a /1000g, ALUM, 15 pack
Product Number: 1600-00-0219
Revision .0C
Coolant canister for use with surgical laser. Terminated |
GEX | None listed |
| Oct 24, 2019 | Candela Corporation Canister HFC-134a /1000g, ALUM
Product Number: 1600-00-0218
Revision .0C
Coolant canister for use with surgical laser. Terminated |
GEX | None listed |
| Oct 18, 2019 | Xintec 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 |
GEX | K992866 |
| Aug 1, 2019 | Aerolase Corporation LightPod Neo Lasers Terminated |
GEX | None listed |
| Aug 1, 2019 | Aerolase Corporation LightPod ERA lasers Terminated |
GEX | None listed |
| Jul 8, 2019 | Medtronic 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 |
GEX | K071328 |
| Jun 27, 2019 | Angiodynamics, Inc. AngioDynamics VenaCure EVLT NeverTouch Procedure Kit, 45CM NEVERTOUCH FRS .018 PROCEDURE KIT PG, Catalog Number 11403012 Terminated |
GEX | K112600 |
| May 22, 2019 | Boston 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 |
GEX | K111475 |
| May 22, 2019 | Boston 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 |
GEX | K111475 |
| May 22, 2019 | Boston 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 |
GEX | K111475 |
| May 22, 2019 | Boston 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 |
GEX | K111475 |
| May 22, 2019 | Boston 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 |
GEX | K111475 |
| May 22, 2019 | Boston 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 |
GEX | K111475 |
| May 22, 2019 | Boston 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 |
GEX | K111475 |
| May 22, 2019 | Boston 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 |
GEX | K111475 |
| May 22, 2019 | Boston 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 |
GEX | K111475 |
| Apr 1, 2019 | Dornier 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 |
GEX | K083500 |
| Oct 17, 2018 | Leoni 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 |
GEX | K050738 |
| Oct 17, 2018 | Leoni 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 |
GEX | K050738 |
| Oct 17, 2018 | Leoni 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 |
GEX | K050738 |
| Oct 17, 2018 | Leoni 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 |
GEX | K050738 |
| Oct 17, 2018 | Leoni 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 |
GEX | K050738 |
| Mar 23, 2018 | Medtronic 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 |
GEX | K053087 |
| Mar 20, 2018 | Monteris Medical Corp MONTERIS MEDICAL NEUROBLATE SYSTEM, used for MRI-guided neurosurgical ablation. Terminated |
GEX | K171255 |
| Mar 5, 2018 | Boston Scientific Corporation Auriga XL 4007 Laser System, Universal Part Number: M0068FS4007G0.
Intended to be used in surgical procedures. Terminated |
GEX | K111475 |
| Mar 5, 2018 | Boston Scientific Corporation Auriga 30 Laser System, Universal Part Number: M0068S30G0.
Intended to be used in surgical procedures. Terminated |
GEX | K111475 |
| Feb 27, 2018 | Iridex 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 |
GEX | K170718 |
| Jul 27, 2017 | Medtronic 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 |
GEX | K053087 |
| Jul 3, 2017 | Beijing Syntech Laser Co., Ltd Beijing Syntech Laser UL Station
surgical lasers Open, Classified |
GEX | None listed |
| Jul 3, 2017 | Beijing Syntech Laser Co., Ltd Beijing Syntech Laser Nice Station Light Based Platform
surgical lasers Open, Classified |
GEX | None listed |
| Jul 3, 2017 | Beijing Syntech Laser Co., Ltd Beijing Syntech Laser APOLLO JV+ Medical Platform
surgical lasers Open, Classified |
GEX | None listed |
| Jul 3, 2017 | Beijing Syntech Laser Co., Ltd Beijing Syntech Laser APOLLO V+ Medical Platform
surgical lasers Open, Classified |
GEX | None listed |
| Jul 3, 2017 | Beijing Syntech Laser Co., Ltd Beijing Syntech Laser UL C02 Laser
surgical lasers Open, Classified |
GEX | None listed |
| Jul 3, 2017 | Beijing Syntech Laser Co., Ltd Beijing Syntech Laser Trixel 11 C02 Laser
surgical lasers Open, Classified |
GEX | None listed |
| Jul 3, 2017 | Beijing Syntech Laser Co., Ltd Beijing Syntech Laser Trixel C02 Laser
surgical lasers Open, Classified |
GEX | None listed |
| Jul 3, 2017 | Beijing Syntech Laser Co., Ltd Beijing Syntech Laser Diode Laser
surgical lasers Open, Classified |
GEX | None listed |
| Jul 3, 2017 | Medtronic 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 |
GEX | K053087 |
| Jun 23, 2017 | Xintec 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 |
GEX | K992866 |
| Jun 6, 2017 | Laserex 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 |
GEX | None listed |
| Jun 5, 2017 | Cook Inc. Cook Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages Terminated |
GEX | K124030 |
| May 3, 2017 | Cook 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 |
GEX | K073496 |
| Mar 27, 2017 | Strata 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 |
GEX | None listed |
| Oct 23, 2016 | Lumenis Limited FemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch" Tip (SPSA-20002590)
Provide fractional treatments in gynecology. Terminated |
GEX | K100415 |
| Sep 19, 2016 | New 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 |
GEX | None listed |
| Sep 19, 2016 | New 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 |
GEX | K103338 |
| Sep 19, 2016 | New 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 |
GEX | K101784 |
| May 16, 2016 | Medtronic 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 |
GEX | K053087 |
| May 16, 2016 | Monteris 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 |
GEX | K143457 |
| May 13, 2016 | Lumenis Ltd Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-1014971). Terminated |
GEX | K142860 |
| May 5, 2016 | Ellipse A/S Ellipse ND: YAG Laser applicator for Ellipse Nordlys system
Medical Laser Products. Terminated |
GEX | None listed |
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