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510(k) Data Aggregation

    K Number
    K072152
    Device Name
    JUNIPER CLN1 DERMAL COOLING DEVICE
    Manufacturer
    JUNIPER MEDICAL INC.
    Date Cleared
    2007-09-07

    (35 days)

    Product Code
    ILO
    Regulation Number
    890.5720
    Why did this record match?
    Applicant Name (Manufacturer) :

    JUNIPER MEDICAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Juniper CLN1 Dermal Cooling Device is intended for use as a skin cooling device to minimize pain and thermal injury during laser and dermatological treatments. Alternative uses include skin cooling as a local anesthetic for procedures that induce minor local discomfort. The Juniper CLN1 Dermal Cooling Device can also provide localized thermal therapy (hot or cold) to minimize pain for post traumatic and / or post surgical pain and to temporarily relieve minor aches and pains and muscle spasms. The optional massage function can also be used for the relief of minor muscle aches, pain, and spasm and for the improvement in local circulation and temporary reduction in the appearance of cellulite. The Juniper Medical Coupling Gels 400 and 600 facilitate thermal contact of Juniper Dermal Cooling Devices with a patient's skin by mitigating minor variances in device-toskin contact.
    Device Description
    The Juniper CLN1 Dermal Cooling Device is a thermoelectric cooling and heating device that applies controlled cooling or heating to a treatment site. The device also includes the option of electrically powered massage.
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    K Number
    K063715
    Device Name
    JUNIPER COOLING DEVICE XTRA
    Manufacturer
    JUNIPER MEDICAL INC.
    Date Cleared
    2007-02-05

    (53 days)

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

    JUNIPER MEDICAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Juniper Cooling Device XTRA is intended for use as a skin cooling device to minimize pain and thermal injury during laser and dermatological treatments. Alternative uses include skin cooling as a local anesthetic for procedures that induce minor local discomfort. The Juniper Cooling Device XTRA can also provide localized thermal therapy (hot or cold) to minimize pain for post traumatic and / or post surgical pain and to temporarily relieve minor aches and pains and muscle spasms. The optional massage function can also be used for the relief of minor muscle aches, pain, and spasm and for the improvement in local circulation and temporary reduction in the appearance of cellulite. The Juniper Medical Coupling Gel facilitates thermal contact of the Juniper Cooling Device XTRA with a patient's skin by mitigating minor variances in device-to-skin contact.
    Device Description
    Not Found
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