BEUDAMED
    Product Code: PFP FDA class 1 21 CFR 878.4025

    Silicone Hydrogel For Scar Management

    General, Plastic Surgery

    Silicone Hydrogel for Scar Management is a topical device used for the management of closed hyperproliferative scars, including hypertrophic and keloid scars. It is an FDA Class 1 device regulated under 21 CFR 878.4025, subject to general controls but not exempt from premarket notification requirements. The product code is PFP, assigned to the General and Plastic Surgery (SU) medical specialty. This device does not carry implant or life-sustaining flags.

    View on FDA
    510(k)s
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    PFP
    Device Class
    FDA class 1
    Regulation Number
    878.4025
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    4

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    Management of closed hyperproliferative (hypertrophic and keloid) scars.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K131672 MICROCYN SCAR MANAGEMENT HYDROGEL

    FEI Numbers

    This FDA classification entry is associated with 41 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 41 registration numbers. Click on an entry to view related FDA registrations.