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510(k) Data Aggregation

    K Number
    K973773
    Device Name
    DAPELLE HAIR REMOVER
    Manufacturer
    WELLQUEST INTL., INC.
    Date Cleared
    1997-12-17

    (76 days)

    Product Code
    KCX
    Regulation Number
    878.5360
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    DAPELLE HAIR REMOVER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Intended use for this product is to remove unwanted hair.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a device called "Dapelle™ Hair Remover." It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, or training set details.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document primarily focuses on regulatory approval and classification, not on the detailed technical or clinical performance evaluation of the device.

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