LogoFDA 510(k) Search
Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K060966
    Device Name
    COOLTOUCH VARIA ND:YAG LASER SYSTEM
    Manufacturer
    COOLTOUCH, INC.
    Date Cleared
    2006-07-31

    (115 days)

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

    COOLTOUCH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CoolTouch Varia Laser System and accessories are indicated for use in Dermatological applications for the treatment of fine lines and wrinkles.
    Device Description
    The CoolTouch, Inc. CoolTouch "Varia" Nd:YAG Surgical Laser is a laser producing emissions at 1064nm. The lasers consist of several interconnected sections: the cabinet, which houses the power supply, cooling system, microcontroller, and the laser head, the fiber optics, and the handpiece. The systems provide safety features that are designed to protect the user and patient from high voltages and laser emissions.
    Ask a Question
    K Number
    K040921
    Device Name
    COOLTOUCH, MODEL NS 160
    Manufacturer
    COOLTOUCH, INC.
    Date Cleared
    2004-09-28

    (173 days)

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

    COOLTOUCH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CoolTouch NS-160 Nd: YAG Laser System is indicated for the treatment of reflux of the greater saphenous vein associated with varicose veins and varicosities.
    Device Description
    The CoolTouch NS-160 Nd:YAG Laser System is an ND:YAG laser producing laser emission at 1320 nm. The laser consists of two sections: The cabinet, which houses the power supply, cooling system, microcontroller and the laser, and the fiber optic.
    Ask a Question

    Page 1 of 1