LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K030948
    Device Name
    VMATE MODEL VMM1000
    Manufacturer
    HOWARD INSTRUMENTS, INC.
    Date Cleared
    2003-06-17

    (83 days)

    Product Code
    HQE
    Regulation Number
    886.4150
    Type
    Traditional
    Panel
    Ophthalmic (OP)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VMATE MODEL VMM1000

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    An electrically powered ophthalmic device intended to remove vitreous matter from the vitreous cavity

    Device Description

    An electrically powered ophthalmic device intended to remove vitreous matter from the vitreous cavity

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter for the VMate™ Vitreous Cutting System. This document focuses on the regulatory clearance for a medical device and does not contain information about acceptance criteria, study designs, sample sizes, ground truth establishment, or expert involvement as requested in your prompt regarding an AI/algorithm-based device.

    Therefore, I cannot extract the information required to populate the table and answer the subsequent questions from this document.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1