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510(k) Data Aggregation

    K Number
    K020513
    Device Name
    EPY-50
    Manufacturer
    DDC TECHNOLOGIES, INC.
    Date Cleared
    2002-05-16

    (90 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    EPY-50

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    1. The EPY-50 PULSED Nd: YAG LASER is intended to effect TEMPORARY HAIR REDUCTION in skin types I-IV.
    2. The EPY-50 PULSED Nd: YAG LASER is also intended to effect STABLE LONG-TERM, OR PERMANENT, HAIR REDUCTION in skin types I-IV through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as a long-term stable reduction in the number of hairs re-growing after a treatment regimen.
    3. VASCULAR LESIONS.
    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for the EPY-50 PULSED Nd:YAG LASER. It does not contain the information requested about acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications for proving the device meets acceptance criteria.

    The letter primarily:

    • Confirms that the device is substantially equivalent to legally marketed predicate devices.
    • Lists the indications for use for the device.
    • Outlines general regulatory requirements.

    Therefore, I cannot provide the requested table and study details based on the input document.

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