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510(k) Data Aggregation

    K Number
    K051103
    Device Name
    HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORY
    Manufacturer
    HAAG-STREIT USA, INC.
    Date Cleared
    2005-06-07

    (39 days)

    Product Code
    HJK
    Regulation Number
    886.1385
    Why did this record match?
    Applicant Name (Manufacturer) :

    HAAG-STREIT USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Haag-Streit Contact Glasses are a family of diagnostic and therapeutic contact lenses used in the examination of the eye fundus, retina and irido-corneal angle, and for the laser therapy of intraocular abnormalities.
    Device Description
    The HS Contact Glasses is a family of diagnostic and therapeutic contact lenses used for eye examination and therapy of intraocular abnormalities. The HS Contact Glass family is designed around the classic Goldmann contact lenses. All HS Contact Glass models are of similar design, but provide different optical elements to provide excellent visualization of the ocular anatomical areas for the particular intended use. When used in conjunction with the HS 900 slit-lamp, the HS Contact Glasses provide a binocular and stereoscopic view of the specific optical region of the eye. The HS Contact Glass typically consists of an aluminum housing, one or more mirror elements and a carved of time directly on the globe or cornea of the eye. The HS contact glass family has two principal modes of use. Those used with laser radiation for therapy of ocular abnormalities. HS Contact Glasses used in diagnostic procedures are made of acrylic plastic (PMMA). These are doolgnou with slit-lamps, such as fundus, the vitreous and the may of HS diagnostic Contact Glasses have the Flaag Otreit Bookine by Goldmann: 59/ 66/ 73 degrees.
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