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510(k) Data Aggregation

    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
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K041554,K051268,K052442,K060411,K040081,K041086,K043319
    Why did this record match?
    Device Name :

    AESTHERA PHOTOPNEUMATIC (PPX) SYSTEM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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.

    AI/ML Overview

    The provided text is a 510(k) summary for the Aesthera Photopneumatic™ (PPx™) System. It describes the device, its indications for use, and its substantial equivalence to predicate devices. However, it does not contain detailed information about specific acceptance criteria, a formal study design with performance metrics, sample sizes for test sets, data provenance, expert qualifications, or adjudication methods typically found in clinical trial reports or detailed performance studies.

    The document states: "Clinical data demonstrating the safety and effectiveness of the Aesthera Photopneumatic™ (PPx™) System for the treatment of mild to severe acne, including pustular acne, comedonal acne, and mild to moderate inflammatory acne (acne vulgaris) was provided." However, it does not elaborate on the specifics of this clinical data.

    Therefore,Based on the provided text, I cannot complete the requested tables and information. The document is a 510(k) summary focused on substantial equivalence, and it lacks the detailed performance study information required to answer your questions.

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