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510(k) Data Aggregation

    K Number
    K021936
    Device Name
    MOIST PUNCTAL PLUG SYSTEM
    Manufacturer
    MOIST MEDICAL INC.
    Date Cleared
    2002-10-16

    (126 days)

    Product Code
    LZU
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    MOIST MEDICAL INC.

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

    Punctum plugs are indicated for the treatment of dry eye disorder. A condition caused by insufficient moisture in the eye. As a result, one may experience some irritation and discomfort to the eyes. Patients that may benefit from the use of punctum plugs are: sufferers of allergies, cataracts, dry eye secondary to contact lens use, and others who experience dry eye disorders. Specific treatment to stop the outflow of tears via a punctal opening (upper/lower) in order to increase tear flow on the surface of the eye.

    Device Description

    MOIST Punctal Plug System

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to MOIST Medical, Inc. regarding their MOIST Punctal Plug System. This document does not contain information about acceptance criteria or a study proving the device meets those criteria.

    The letter primarily:

    • Acknowledges receipt and review of the 510(k) submission.
    • States that the device is substantially equivalent to legally marketed predicate devices.
    • Informs the company that they can market the device subject to general controls and other applicable regulations.
    • Provides contact information for further questions.

    Therefore, I cannot extract the requested information from this document. The document confirms the device's classification and allows its market entry based on substantial equivalence to existing devices, rather than through a performance study against specific acceptance criteria described in this letter.

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