LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K012096

    Validate with FDA (Live)

    Device Name
    DISPOSABLE VITRECTOMY LENS
    Manufacturer
    OCULAR INSTRUMENTS, INC.
    Date Cleared
    2001-08-24

    (50 days)

    Product Code
    HJK
    Regulation Number
    886.1385
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Predicate For
    K033950,K050623,K051630,K142715,K173944
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Allow visualization of the ocular fundus, vitreous, and retinal structures during vitrectomy surgery.

    Device Description

    Disposable Vitrectomy Lens

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a Disposable Vitrectomy Lens. It does not contain information about acceptance criteria or a study proving the device meets them. The letter simply states that the FDA has reviewed the 510(k) notification and found the device to be substantially equivalent to devices marketed prior to May 28, 1976.

    Therefore, I cannot provide the requested information from the provided text. The document is an approval letter, not a study report.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1