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510(k) Data Aggregation

    K Number
    K973146
    Device Name
    MENTOR SUPER ABSORBENT DRAPE
    Manufacturer
    MENTOR OPHTHALMICS, INC.
    Date Cleared
    1997-12-04

    (104 days)

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

    MENTOR OPHTHALMICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mentor Absorbent Drape is used to absorb fluids during surgical procedures.
    Device Description
    The Mentor Absorbent Drape measures 29 X 35 inches and is comprised of layered absorbent material between a permeable spunbond layer and a non-permeable layer. The device is packaged sterile for single use only.
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    K Number
    K971538
    Device Name
    MENTOR GEMINI HEMOSTATIC ERASER
    Manufacturer
    MENTOR OPHTHALMICS, INC.
    Date Cleared
    1997-07-14

    (77 days)

    Product Code
    HQO
    Regulation Number
    886.4115
    Why did this record match?
    Applicant Name (Manufacturer) :

    MENTOR OPHTHALMICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mentor® Gemini™ Hemostatic Eraser™ is used to achieve episcleral and or intraocular hemostasis utilizing diathermy.
    Device Description
    The MENTOR® GEMINI™ HEMOSTATIC ERASER™ is a hand-held bipolar probe used for coagulation which consists of (a) a handle and (b) a disposable tip (electrode). The handle transfers RF energy to the disposable tip via a unique electrical contact system located in the internal cavity of the handle. After a single use, the Tip is intended to be disposed of in a safe and cost effective manner. The handle is intended to be used 1-50 times before discarding.
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    K Number
    K964312
    Device Name
    MENTOR TONO-PEN 3
    Manufacturer
    MENTOR OPHTHALMICS, INC.
    Date Cleared
    1996-11-26

    (28 days)

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

    MENTOR OPHTHALMICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MENTOR TONO-PEN 3 is used to measure the intraocular pressure (IOP) during routine eye examination or when an increased IOP is suspected.
    Device Description
    The MENTOR TONO-PEN 3 is a precision electronic tonometer which measures intraocular pressure [IOP]. The body of the instrument is specially designed to fit comfortably in the user's hand, facilitating fast and accurate measurements. TONO-PEN 3 contains an elemental silicon strain gage which converts intraocular pressure to an electrical signal. The pen displays each valid reading on a liquid crystal display [LCD]. When four valid readings are obtained, a mean IOP reading and an indication of reliability are shown on the LCD. The TONO-PEN 3 has a molded plastic tip which must be covered by a latex protective membrane. MENTOR Ocu-Film Tip covers are recommended.
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    K Number
    K960765
    Device Name
    MENTOR ADVENT A/B SYSTEM
    Manufacturer
    MENTOR OPHTHALMICS, INC.
    Date Cleared
    1996-08-08

    (164 days)

    Product Code
    IYO
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    MENTOR OPHTHALMICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MENTOR® Advent™ A/B System is a dual function ultrasonic ophthalmic imaging system. The A-scan is used to measure the axial length of the eye. The system includes various programs for calculating the optical power of the IOL to be implanted during cataract surgery. Anterior chamber depth and lens thickness of the eye are also measured and displayed. The B-scan is used to image the internal structure of the eye including the opaque media and posterior pathology for the purpose of diagnosing pathological or traumatic conditions in the eve.
    Device Description
    MENTOR® Advent™ A/B System is an easy to use ophthalmic ultrasonic system, offering capabilities and versatility for both A-scan and B-scan operations. The A-Scan biometric unit of the Advent System has the following features: Operational modes - Automatic and Manual Probe alignment - LED fixation light and audio feedback Multiple eye categories - Normal, Aphakic, Cataractous, Dense Cataractous and Pseudophakic IOL calculations - programs include the latest in SRK, Holladay and Hoffer Q Patient storage - up to 16 patients, including right and left eye User interface - standard computer keyboard Display - 9" high resolution white phosphor CRT Accessories - printer, video output The B-Scan imaging unit of the Advent System has the following features: Scanning - 50 degrees sector scan probe, allowing eye view from wide variety of angles Normal mode - requires selection of parameters Windowed mode - allows user selectable scanning angle Controls - depth, gain, contrast and brightness Display - 9" high resolution white phosphor CRT User interface - standard computer keyboard Accessories - camera, printer. VCR MENTOR Advent™ System uses the following transducer operations and characteristics: A-Scan: There is a single ultrasound mode where the transducer is pulsed at a repetition frequency of approximately 5 Hz. The transducer is a non-scanning crystal with a frequency of approximately 8 Mhz. This system uses the same ultrasound transducer as in the predicate device. B-Scan: There are two ultrasound modes, Normal and Windowed. The transducer is a single crystal mechanical sector probe with a center frequency of 11 MHz. It is housed in an oil-filled sealed chamber. The transducer sweeps 8 frames/sec. Sweep angle is 50°, pulse repetition frequency is 5.5 KHz and there are 275 transmitted lines per scan. In the Windowed mode, the size and position of the user selected window affects the pulse rate and spacing of the pulse, and thus the radiated field. Ultrasonic power measurements reported later have been made in the worst case condition,
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