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510(k) Data Aggregation

    K Number
    K132917
    Device Name
    OCULAR FORCE GAUGE
    Manufacturer
    OCULAR THERAPEUTIX, INC.
    Date Cleared
    2013-12-20

    (94 days)

    Product Code
    HKY
    Regulation Number
    886.1930
    Why did this record match?
    Applicant Name (Manufacturer) :

    OCULAR THERAPEUTIX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Ocular Force Gauge is indicated for applying measured force to the surface of the eye.
    Device Description
    The Ocular Force Gauge is a non-sterile, reusable, precision spring-scale manual instrument designed and manufactured to apply measured force to the surface of the eye. The hand held device has a smooth "foot" similar to the "foot" of an opthalmodynamometer, an instrument used to apply and measure force on the ocular surface. The Ocular Force Gauge "foot" is the surface of the device that contacts the ocular surface.
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