BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    Resultz Lice & Egg Removal Kit

    K Number: K151562 · Decision May 8, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    48
    Same Product Code
    10
    Applicant Total
    1
    Review Days
    698

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Resultz Lice & Egg Removal Kit
    K Number
    K151562
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5960
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Piedmont Pharmaceuticals, LLC
    Date Received
    June 10, 2015
    Decision Date
    May 8, 2017
    Product Code
    LJL
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LJL Detectors And Removers, Lice, (Including Combs)

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (LJL), ordered by most recent decision date.

    Nix Ultra Lice Treatment Kit

    FDA 510(k)
    FDA Class 1 ·General Hospital

    LOUSEBUSTER

    FDA 510(k)
    FDA Class 1 ·General Hospital

    LOUSEBUSTER

    FDA 510(k)
    FDA Class 1 ·General Hospital

    KLOUT SHAMPOO AND LICE COMBING PRETREATMENT KIT

    FDA 510(k)
    FDA Class 1 ·General Hospital

    CLEAR (TM) LICE EGG REMOVER SYSTEM

    FDA 510(k)
    FDA Class 1 ·General Hospital

    LICEMEISTER COMB

    FDA 510(k)
    FDA Class 1 ·General Hospital
    View all