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510(k) Data Aggregation

    K Number
    K151816
    Device Name
    TLC-2000 Therapeutic Medical Laser System
    Manufacturer
    Theralase Inc.
    Date Cleared
    2015-11-19

    (136 days)

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

    Theralase Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Theralase TLC-2000 Therapeutic Medical Laser System is in the temporary relief of pain associated with knee disorders with standard chiropractic practice.
    Device Description
    Not Found
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    K Number
    K050342
    Device Name
    THERALASE TLC-1000 THERAPEUTIC MEDICAL LASER SYSTEM
    Manufacturer
    THERALASE INC.
    Date Cleared
    2005-07-11

    (150 days)

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

    THERALASE INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Theralase™ TLC-1000 Therapeutic Medical Laser System is indicated for adjunctive use in the temporary relief of pain associated with knee disorders with standard chiropractic practice.
    Device Description
    The Theralase™ TLC-1000 Therapeutic Medical Laser System is a non-heating infrared lamp as defined in 21 CFR 890.5500. The TLC-1000 system is a precision medical device as wontion of a hand held portable multiple laser probe (5 x 905 NIR laser diodes and 4 x 660 visible red laser diodes) and a laser controller unit with a rechargeable battery.
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