LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K991312
    Device Name
    SOOTHE & SMOOTH SCAR CARE - SILICONE SHEETING
    Manufacturer
    LIBRARY MEDICAL, INC.
    Date Cleared
    1999-08-20

    (126 days)

    Product Code
    MDA
    Regulation Number
    878.4025
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    To be used in the management of Hypertrophic and Keloid scars that are the result of surgery, trauma, and burns. Also, LMI Scar Management Silicone Sheeting may prevent Hypertrophic and Keloid scars from forming.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the LMI Scar Management device, indicating it has been found substantially equivalent to a predicate device. It does not contain information on acceptance criteria or a study proving device performance against such criteria. The letter primarily addresses regulatory approval based on substantial equivalence, not a detailed performance study. Therefore, I cannot provide the requested information from the given text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1