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510(k) Data Aggregation

    K Number
    K090938
    Device Name
    FLOW CONTROLLER
    Manufacturer
    ODYSSEY MEDICAL, INC.
    Date Cleared
    2009-06-04

    (62 days)

    Product Code
    LZU
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    ODYSSEY MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Punctal Occluders (plugs) are indicated for the treatment of "dry eye" syndrome.
    Device Description
    This device, made of medical grade silicone, titanium dioxide as a colorant and utilizing a proprietary surface treatment made under current good manufacturing practices, is a small, generally "plug" shaped design. Punctal Occluders are intended for the treatment of "dry eve" conditions through partial occlusion of individual punctual openings.
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    K Number
    K042977
    Device Name
    LASIK EYE DRAPE
    Manufacturer
    ODYSSEY MEDICAL, INC.
    Date Cleared
    2005-05-10

    (194 days)

    Product Code
    KKX
    Regulation Number
    878.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    ODYSSEY MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Odyssey's L.E.D. provides a sterile adhesive surgical barrier for a variety of ophthalmic procedures, including LASIK. Prepare and drape the patient in the normal ophthalmic fashion. Hold back the eyelashes from the visual field as required. Care should be taken when removing the drape from the adhesive backing not to tear or damage the device. Apply the L.E.D. in the required area to provide proper occlusion and maintain a clean and dry sterile field. The Lasik Eyelid Drape is designed to drape the eyebrow, completely drape the perimeter of the eye or provide complete occlusion of the eyelid. It can also be trimmed to aid in retracting lashes without obstructing the surgical site. While the adhesive holds the drape securely in place, removal is easy and painless for patients. A non-adhesive red tab is located on each side of the drape to aid in removal.
    Device Description
    This device, made of medical grade polyethylene tape and coated with a pressure sensitive acrylate adhesive, is designed to support LASIK surgery, as well as a variety of other ophthalmic procedures by promoting a clean and dry sterile field. The LASIK Evelid Drape is intended by design to drape the eyebrow, completely drape the eye or provide complete occlusion of the eyelid. In addition, it can be trimmed to aid in retracting lashes without obstructing the surgical site.
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    K Number
    K972523
    Device Name
    PUNCTUAL OCCLUDER
    Manufacturer
    ODYSSEY MEDICAL, INC.
    Date Cleared
    1997-09-09

    (64 days)

    Product Code
    LZU
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    ODYSSEY MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Punctal Occluders (plugs) are indicated for the treatment of "dry eye" syndrome. "dry eye being a condition where there is insufficient lubrication in the eye and the conjunctive becomes much less moist than normal. This produces pain and discomfort in the eyes. This may occur in any condition that causes scars of the cornea, such as erythema multiforme, trachoma, or corneal burns;" ... etc. Other patients that may benefit are: cataract patients, patients with arthritis, patients medicated for hypertension, contact wearers of any age, seasonal allergy sufferers, patients who live in dry climates, or spend extended periods in air conditioning, and any others who suffer from dry eye irritation. Treatment is to stop tear outflow via a specific punctum to enhance tear contact time in certain dry eye conditions. It is also reasonable that eye drops of many kinds would be more effective if retained on the surface of the eye, rather than drained into the sinus.
    Device Description
    This device, made of medical grade silicone, titanium dioxide as a colorant and utilizing a propritary surface treatment made under current good manufacturing practices, is a small, generally "plug" shaped design. Punctal Occluders are intended for the treatment of "dry eye" conditions through the total occlusion of individual punctal openings.
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    K Number
    K970631
    Device Name
    PUNCTUAL OCCLUDER
    Manufacturer
    ODYSSEY MEDICAL, INC.
    Date Cleared
    1997-04-23

    (63 days)

    Product Code
    LZU
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    ODYSSEY MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Punctal Occluders are intended for the treatment of "dry eye" conditions through the total occlusion of individual punctal openings.
    Device Description
    This device, made of medical grade silicone and titanium dioxide as a colorant under current good manufacturing practices, is a small, generally "plug" shaped design.
    Ask a Question

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