LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

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
    Why did this record match?
    Applicant Name (Manufacturer) :

    IGIA DIRECT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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
    Ask a Question

    Page 1 of 1