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510(k) Data Aggregation

    K Number
    K173067
    Device Name
    LightForce LTS Model 1000, 1500, 2500, and 4000
    Manufacturer
    LiteCure, LLC
    Date Cleared
    2018-02-22

    (146 days)

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

    LiteCure, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    810 nm and 980 nm wavelength: The LTS-1000/1500/2500/4000 devices emit energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and the temporary relaxation of muscle. 980 nm wavelength: The LTS-2500/4000 devices are also indicated for use in surgical applications requiring hemostasis, ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), gastroenterology, general surgery, genitourinary surgery (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT), ophthalmology, arthroscopy, podiatry, pulmonology, thoracic surgery; and Laser Assisted Lipolysis. 980 nm wavelength: The LTS-2500/4000 devices are also indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophyton rubrum and Trichophyton mentagrophytes, and/or yeasts Candida albicans, etc.)
    Device Description
    The LTS Product Family of devices are highly reliable, compact and easy to operate medical lasers. The Console Assembly incorporates a touch-screen display panel and a Main Processor PCA. A Software Application, executed in the Main Processor PCA, generates an intuitive, easy to use, Graphical User Interface (GUI) and responds to operator input, via the touch panel, allowing the operator to select from build-in treatment protocols, or adjust and set the system's optical output power and treatment times with minimal effort. Laser light generated by the Laser Module Sub-Assembly in the Console Assembly is delivered to a subject via a custom designed Beam Delivery Assembly that can be fitted with different Hand Piece Attachments. The various hand piece attachments are designed to allow the operator to deliver, indication specific optimized dose parameters (for example, onychomycosis).
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    K Number
    K123014
    Device Name
    LITECURE THERAPY SYSTEM MODEL LTS-1500
    Manufacturer
    LITECURE, LLC
    Date Cleared
    2013-03-29

    (183 days)

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

    LITECURE, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    810 nm and 980nm wavelength: LiteCure Therapy System, Model L TS-1500 is indicated for emitting energy in the infrared Spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation. 980nm wavelength: LiteCure Therapy System, Model L TS-1500 is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and Tmentagrophytes, and/or yeasts Candida albicans, etc.).
    Device Description
    Not Found
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    K Number
    K123031
    Device Name
    BWF-5 MEDICAL LASER SERIES
    Manufacturer
    LITECURE, LLC
    Date Cleared
    2012-12-03

    (66 days)

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

    LITECURE, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BWF-5 Medical Laser Series (810nm, 930nm, 1080nm and 1320nm) are intended for delivery of laser light to soft tissue in the contact or non-contact mode during surgical procedures, including via endoscopes, introducers, or catheters. The BWF-5 Medical Laser Series are generally indicated for incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolary). And and procedures, arthroscopy, gastroenterology, general surgery, dermatology, glastic, sugery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery and thoracic surgery. The device is specifically indicated for use as follows: LASER 980nm: Indicated for use with the VARI-LASE Procedure Kit in the Endovascular coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux. LASER 1320mm: Indicated for use with the VARI-LASE Procedure Kit in the treatment of reflux of great saphenous veins associated with varicose veins and varicosities. LASER 810nm: Indicated for use in the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein and for treatment of incompetence and reflux of superficial veins in the lower extremity.
    Device Description
    Not Found
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    K Number
    K121487
    Device Name
    LITECURE THERAPY COMPACT
    Manufacturer
    LITECURE, LLC
    Date Cleared
    2012-06-12

    (25 days)

    Product Code
    ILY
    Regulation Number
    890.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    LITECURE, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LiteCure Therapy Compact (Model LTC-900 and LTC-1200) is indicated for emitting energy in the infrared Spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation.
    Device Description
    Not Found
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    K Number
    K103511
    Device Name
    LITECURE THERAPY SYSTEM
    Manufacturer
    LITECURE, LLC
    Date Cleared
    2011-01-25

    (56 days)

    Product Code
    ILY
    Regulation Number
    890.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    LITECURE, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LiteCure Therapy System, Model LTS-1500 is indicated for emitting energy in the infrared Spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation.
    Device Description
    LiteCure Therapy System, Model LTS-1500 is a compact medical laser system. The laser light delivery system consists of a flexible optical fiber threaded through a lightweight handpiece. Activation occurs when the operator enables the laser and presses the foot/finger switch. Depending on laser system configuration, the foot/finger switch can function as on/off switch. A touch-screen display panel allows the operator to adjust or set laser output level. The laser can operate in continuous wave mode or controlled pulse mode.
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    K Number
    K093087
    Device Name
    BWF-5 MEDICAL LASER SERIES
    Manufacturer
    LITECURE, LLC
    Date Cleared
    2010-05-12

    (223 days)

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

    LITECURE, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BWF-5 Medical Laser Series (810nm, 930nm, 980nm, 1080nm and 1320nm) are intended for delivery of laser light to soft tissue in the contact or non-contact mode during surgical procedures, including via endoscopes, introducers, or catheters. The BWF-5 Medical Laser Series are generally indicated for incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery and thoracic surgery. The device is specifically indicated for use as follows: LASER 980nm: Indicated for use with the VARI-LASE Procedure Kit in the Endovascular coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux. LASER 1320nm: Indicated for use with the VARI-LASE Procedure Kit in the treatment of reflux of great saphenous veins associated with varicose veins and varicosities.
    Device Description
    BWF-5 Medical Laser Series are compact medical laser systems. The laser light delivery system consists of a flexible optical fiber. Activation occurs when the operator enables the laser and presses the foot switch. Release the foot switch to deactivate the laser. Depending on laser system configuration, the foot switch can function as on/off switch. A touch-screen display panel allows the operator to adjust or set laser output level. The laser can operate in continuous wave mode or controlled pulse mode.
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    K Number
    K070400
    Device Name
    LC THERAPY, MODEL LCT-1000
    Manufacturer
    LITECURE, LLC
    Date Cleared
    2007-02-28

    (16 days)

    Product Code
    ILY
    Regulation Number
    890.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    LITECURE, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LC Therapy, Model LCT-1000 is indicated for emitting energy in the infrared Spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation.
    Device Description
    LC Therapy, Model LCT-1000 Laser is a compact medical laser system. The laser light delivery system consists of a flexible optical fiber threaded through a lightweight wand. Activation occurs when the operator enables the laser and presses the foot switch. Release the foot switch to deactivate the laser. Depending on laser system configuration, the foot switch can function as on/off switch. A touch-screen display panel allows the operator to adjust or set laser output level. The laser can operate in continuous wave mode or controlled pulse mode.
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