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510(k) Data Aggregation

    K Number
    K220531
    Device Name
    FOX 810, FOX 980
    Manufacturer
    A.R.C. Laser GmbH
    Date Cleared
    2022-09-01

    (189 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    A.R.C. Laser GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FOX 810: Indicated for surgical applications requiring the ablation, vaporization, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, otolaryngology, and pulmonology. FOX 980: Indicated for surgical applications requiring the ablation, vaporization, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, genitourinary, gynecology, neurosurgery, otolaryngology, orthopedics, pulmonology, and thoracic surgery.
    Device Description
    The FOX Lasers are a family of products with a laser diode as the beam source. Dependent on the chosen diode, the laser system can radiate one factory set wavelength with either 810nm or 980mm. The FOX is a compact diode laser with a high-resolution color touchscreen for user control.
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    K Number
    K192272
    Device Name
    Wolf445nm
    Manufacturer
    A.R.C. Laser GmbH
    Date Cleared
    2020-03-17

    (208 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    A.R.C. Laser GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Wolf 445nm is intended for incision, vaporization, ablation, hemostasis and coagulation of soft tissue.
    Device Description
    The Wolf Diode Lasers are a family of products with a laser diode as the beam source. Dependent on the chosen diode the laser system can radiate one wavelength with either 445nm, 980nm or 1470nm. This submission refers to and includes only one model, the Wolf 445nm. The Wolf 445nm is a compact diode laser with a high resolution color touchscreen for user control. The laser utilizes a green (532nm) aiming beam diode to indicate the area to be irradiated by the laser beam.
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    K Number
    K170183
    Device Name
    Cetus system, Cetus probe
    Manufacturer
    A.R.C. Laser GmbH
    Date Cleared
    2017-09-27

    (247 days)

    Product Code
    HQE
    Regulation Number
    886.4150
    Why did this record match?
    Applicant Name (Manufacturer) :

    A.R.C. Laser GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cetus Laser System is indicated for use in phacofragmentation of the cataractous crystalline lens.
    Device Description
    The Cetus system is a 1064nm. pulsed, Nd: YAG Q-switched laser system used together with a sterile, single use laser probe and a Phaco machine. The system console has a digital touch screen and it is used in conjunction with the Cetus probe and a Phacoemulsification machine in the operating room. The probe converts the laser light energy into acoustic energy which is used to perform the fragmentation of the the crystalline lens and has integrated aspiration and irrigation functions.
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    K Number
    K161403
    Device Name
    A.R.C. Laser Surgical Fibers and Probes
    Manufacturer
    A.R.C. LASER GMBH
    Date Cleared
    2016-08-16

    (88 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    A.R.C. LASER GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The A.R.C laser surgery fibers and probes are intended for delivery of laser energy to soft tissue in the contact and non-contact mode during surgical procedures, including via endoscopes. The fibers are indicated for use in general surgical applications for incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue. The A.R.C. Laser Surgery Fibers & Probes are indicated for use in General Surgery, Urology, Gynecology and ENT with a cleared compatible laser marketed for the mentioned intended uses and using an SMA 905 connector.
    Device Description
    The A.R.C. surgical laser fibers & probes are single use laser delivery devices provided EO sterile and intended for medical applications in various fields of laser surgery. The devices are based on a quartz core, have a length of 6.5 feet (2 meters) to 9.9 feet (3 meters) and a wavelength range between 450nm to 2100nm. The proximal end of the fibers is connected to a cleared laser system via an SMA 905 connector, while the distal end delivers the laser energy to the target tissue in pulsed and continuous wave mode. The distal end have a bare tip which may be flat or spherical, and may be used with a variety of sterile hand pieces for the various intended uses and effects.
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    K Number
    K091059
    Device Name
    FOXQ 980 LASER
    Manufacturer
    A.R.C. LASER GMBH
    Date Cleared
    2009-08-13

    (121 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    A.R.C. LASER GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fox Q-980 Diode Laser is indicated for surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, genitourinary, gynecology, neurosurgery, otolaryngology, orthopedics, ophthalmology, pulmonology, thoracic surgery and laser assisted lipolysis.
    Device Description
    Fox Q-980 is a standard diode medical laser with 980nm wavelength and quartz fibers
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    K Number
    K073322
    Device Name
    FOX 1-980, FOX Q-1064, FOX-Q-810
    Manufacturer
    A.R.C. LASER GMBH
    Date Cleared
    2008-02-22

    (88 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    A.R.C. LASER GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fox Q-810: indicated for surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, neurosurgery, otolaryngology, ophthalmology, and pulmonology. Fox Q-980: indicated for surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, genitourinary, gynecology, neurosurgery, otolaryngology, orthopedics, ophthalmology, pulmonology, and thoracic surgery. Fox Q-1064: indicated for surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, general surgery, genitourinary, neurosurgery, otolaryngology, orthopedics, ophthalmology, pulmonology, and thoracic surgery.
    Device Description
    Fox Q-810, Q-980 and Q-1064 are standard diode medical lasers with 810, 980nm and 1064nm wavelength, respectively
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