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510(k) Data Aggregation

    K Number
    K083730
    Device Name
    ISOLAZ
    Manufacturer
    AESTHERA CORPORATION
    Date Cleared
    2009-01-09

    (24 days)

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

    AESTHERA CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Isolaz™ is intended to treat benign vascular and pigmented lesions, permanent hair reduction, 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 Isolaz™ System is a portable tabletop system used to deliver non-coherent 400-1200nm, 530-12000mm and 580-1200mm intense pulsed light via a delivery handpiece utilizing photpneumatic technology. The system consists of a main console, a treatment handpiece and a footswitch. The desired power and delivery time are set manually by the operator.
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    K Number
    K062048
    Device Name
    AESTHERA PHOTOPNEUMATIC (PPX) SYSTEM
    Manufacturer
    AESTHERA CORPORATION
    Date Cleared
    2006-09-07

    (49 days)

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

    AESTHERA CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Aesthera Photopneumatic™ (PPx™) System is intended for: - The treatment of benign vascular and pigmented lesions: . - Permanent hair reduction; . - The treatment of mild to moderate acne, including pustular acne, comedonal acne, . and mild to moderate inflammatory acne (acne vulgaris). The Aesthera Photopneumatic™ (PPx™) System is intended for use on all skin types (Fitzpatrick skin types I-VI).
    Device Description
    The Aesthera Photopneumatic™ (PPx™) System is comprised of the following main components: - . Main console - PPx™ Treatment Handpiece . - Optional coolant accessory cryogenic, water, or air spray for cooling the handpiece . tip; and - . Treatment Footswitch. The Aesthera Photopneumatic™ (PPx™) System (with treatment handpiece) is a portable tabletop system used to deliver intense pulsed light to the patient treatment site via a delivery handpiece utilizing Photopneumatic technology. Intense pulsed light is emitted through the IntelliTip™ only when the tip is sealed against the selected patient treatment All emitted light is contained within the IntelliTip™ during treatment. site. The handpiece is uniquely designed to promote increased ergonomics with all user interface and controls located on the handpiece.
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    K Number
    K041554
    Device Name
    AIP INTENSE PULSED LIGHT SYSTEM
    Manufacturer
    AESTHERA CORPORATION
    Date Cleared
    2005-04-27

    (321 days)

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

    AESTHERA CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AIP Intense Pulsed Light System is an intense pulsed light device intended for the following: the treatment of benign vascular and pigmented lesions, and permanent hair reduction. The AIP Intense Pulsed Light System is intended for use on all skin types (Fitzpatrick skin types I-VI).
    Device Description
    The AesThera AIP Intense Pulsed Light System is a 400—1200 nm intense pulsed light delivery system, powered by Photo-Pneumatic™ technology. It is a portable tabletop system with a hand piece connected by an umbilical to the main console. The hand piece incorporates an intelligent tip that is replaced with every patient treatment. A "sealed" intelligent tip is used to transmit light to the patient's skin. Light is emitted only through the tip and is always sealed with the patient's surrounding tissue during intense pulsed light emission. All emitted light is contained within the tip during treatment. The hand niece of the AIP Intense Pulsed Light System is uniquely designed to promote increased ergonomics with all user interface and controls located on the hand piece.
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