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510(k) Data Aggregation

    K Number
    K123889
    Device Name
    ACLEARA, THERACLEAR
    Date Cleared
    2013-03-04

    (76 days)

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

    THERAVANT CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Theravant Acleara/TheraClear System is intended for the treatment of benign vascular and pigmented lesions; permanent hair reduction; and the treatment of mild to moderate acne, including pustular acne, comedonal acne, and mild to moderate inflammatory acne (acne vulgaris), in all skin types (Fitzpatrick I-VI).
    Device Description
    The Theravant System is comprised of the following main components: Main console, Treatment Handpiece(s). The Theravant System is a portable tabletop system used to deliver intense pulsed light to the patient treatment site via a delivery handpiece utilizing vacuum technology. Intense pulsed light is emitted through the tip only when the tip is sealed against the selected patient treatment site. All emitted light is contained within the tip during treatment. A modification to the handpiece includes a needle accessory for use during the treatment of inflammatory acne lesions. The modified handpiece does not introduce any changes to the principles of operation as compared to the traditional handpiece. The modified handpiece uses vacuum to confine and stretch the target region, coupled with a fine gauge needle to facilitate the release of sebum from the pilosebaceous unit.
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    K Number
    K101415
    Device Name
    THERACLEAR
    Date Cleared
    2010-07-08

    (49 days)

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

    THERAVANT CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Theravant TheraClear System is intended for the treatment of benign vascular and pigmented lesions; permanent hair reduction; and the treatment of mild to moderate acne, including pustular acne, comedonal acne, and mild to moderate inflammatory acne (acne vulgaris), in all skin types (Fitzpatrick types I-VI).
    Device Description
    The Theravant System is comprised of the following main components: Main console, Treatment Handpiece(s). The Theravant System is a portable tabletop system used to deliver intense pulsed light to the patient treatment site via a delivery handpiece utilizing vacuum technology. Intense pulsed light is emitted through the tip only when the tip is sealed against the selected patient treatment site. All emitted light is contained within the tip during treatment.
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    Ask a specific question about this device

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