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510(k) Data Aggregation

    K Number
    K040689
    Device Name
    EYE SPHERE IMPLANTS
    Manufacturer
    OCULO PLASTIK, INC.
    Date Cleared
    2004-06-10

    (86 days)

    Product Code
    HPZ
    Regulation Number
    886.3320
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    EYE SPHERE IMPLANTS

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

    Acrylic (PMMA) or Silicone eye sphere implants are permanent implants that occupy the eye cavity when it becomes necessary to surgically remove the eye (enucleation), or the space left after the removal of the contents of the eye ball (evisceration). It is used to replace volume and possibly, given the surgical method, to impart motion to the eventual ocular prosthesis.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification decision letter from the FDA for Eye Sphere Implants. It does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The letter confirms that the device is substantially equivalent to legally marketed devices and can be marketed subject to federal regulations.

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