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    FDA 510(k) FDA class 1 Substantially Equivalent 🇹🇼 Taiwan

    CORELEADER SCAR-DIMMER

    K Number: K111733 · Decision Sep 22, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    190
    Registration Numbers
    190
    Same Product Code
    80
    Applicant Total
    9
    Review Days
    93

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    Basic Information

    Device Name
    CORELEADER SCAR-DIMMER
    K Number
    K111733
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4025
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Coreleader Biotech Co., Ltd.
    Date Received
    June 21, 2011
    Decision Date
    September 22, 2011
    Product Code
    MDA
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MDA Elastomer, Silicone, For Scar Management

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    Other Clearances by Coreleader Biotech Co., Ltd.

    K Number Device Name
    K151204 HEMO-Bandage
    K141382 BIOS KING BIOCELLULOSE FILM
    K123394 CORELEADER HYDRO-HEALER HYDROCOLLOID WOUND DRESSING
    K111578 CORELEADER COLLA-ALGI FIBER MODEL CAW
    K102944 CORELEADER HEMO-PAD MODEL CPII 02030
    K102942 CORELEADER ALGIPLASTER MODEL AP 050501
    K102946 CORELEADER COLLA-PAD MODEL CS 03030
    K102943 CORELEADER ALGI-FIBER WOUND DRESSING MODEL ADW 05050