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510(k) Data Aggregation

    K Number
    K970338
    Device Name
    TWEEZER-TYPE EPILATOR
    Manufacturer
    IGIA DIRECT, INC.
    Date Cleared
    1997-07-01

    (153 days)

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

    IGIA DIRECT, INC.

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

    The sole indication for use of this Class III Tweezer-Type Epilator medical device is for the removal of undesired body hairs using the techniques described in the Owner's Instruction Brochure.

    Device Description

    Class III Tweezer-Type Epilator

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a device called "Elysee Hair Removal System." It primarily grants marketing authorization and does not contain detailed information about acceptance criteria or specific study results to prove device performance.

    Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence to a predicate device, rather than providing a performance study report.

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