Search Filters

Search Results

Found 9 results

510(k) Data Aggregation

    K Number
    K050980
    Device Name
    ULTRASONIC BIO-MICROSCOPE, MODEL P60
    Manufacturer
    PARADIGM MEDICAL INDUSTRIES, INC.
    Date Cleared
    2005-05-26

    (37 days)

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

    PARADIGM MEDICAL INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To acquire and display high resolution images of the anterior segment of the eye. Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic (B-Mode)
    Device Description
    The Model P60 UBM is a PC-based digital instrument that utilizes ultrasonic energy to generate various images of the eye. The pulser circuitry is designed to accept information from the user via a graphical user interface provided by the software. The pulser generates signals specific to the probe installed. The signal acquired from the transducer is translated into an image that is displayed on an LCD monitor.
    Ask a Question
    K Number
    K023245
    Device Name
    BLOOD FLOW ANALYZER (BFA), MODEL 408-100-01
    Manufacturer
    PARADIGM MEDICAL INDUSTRIES, INC.
    Date Cleared
    2002-10-21

    (21 days)

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

    PARADIGM MEDICAL INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Tonometry for Measuring and Recording Intraocular Pressures and Intraocular Pressure Pulse Amplitudes, Pulsatile Ocular Blood Flow, Pulsatile Ocular Blood Volume, Pulsatility Index Equivalent (PEQ).
    Device Description
    The Paradigm Medical Industries, Inc. Blood Flow Analyzer (BFA) is an electronic pneumatic tonometer capable of measuring and recording the intraocular pressure. The pressure measurements are made at a rate of 200 times per second over a period of 5-15 seconds. Contact with the eye is by means of a sterilized single-use per patient probe having an integral membrane that isolates the cornea from the internal pneumatic operation of the BFA. The pulsatile ocular blood flow is derived from the intraocular pressure measurements acquired with the pneumatic tonometer using mathematical equations that link intraocular pressure to ocular volume change and volume flow.
    Ask a Question
    K Number
    K003318
    Device Name
    PHOTON MULTI-PLATFORM SYSTEM, MODEL Z-12834-X & Z-13175-X
    Manufacturer
    PARADIGM MEDICAL INDUSTRIES, INC.
    Date Cleared
    2001-05-22

    (210 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    PARADIGM MEDICAL INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K003141
    Device Name
    UBM PLUS, MODEL P45
    Manufacturer
    PARADIGM MEDICAL INDUSTRIES, INC.
    Date Cleared
    2000-12-05

    (56 days)

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

    PARADIGM MEDICAL INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K002228
    Device Name
    PHOTON MODULAR WORKSTATION SYSTEM, MODELS Z-12834-X & Z-13175-X
    Manufacturer
    PARADIGM MEDICAL INDUSTRIES, INC.
    Date Cleared
    2000-10-06

    (74 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    PARADIGM MEDICAL INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K981109
    Device Name
    QUITETIP
    Manufacturer
    PARADIGM MEDICAL INDUSTRIES, INC.
    Date Cleared
    1998-06-09

    (74 days)

    Product Code
    HQC
    Regulation Number
    886.4670
    Why did this record match?
    Applicant Name (Manufacturer) :

    PARADIGM MEDICAL INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The QuiteTip™ I/A handpiece and tips are used in ophthalmic surgery to provide controlled aspiration of lens tissue while maintaining anterior chamber shape by replacing aspirated fluids with BSS.
    Device Description
    I/A Handpiece and Tips
    Ask a Question
    K Number
    K974719
    Device Name
    PHACOPAK
    Manufacturer
    PARADIGM MEDICAL INDUSTRIES, INC.
    Date Cleared
    1998-01-20

    (33 days)

    Product Code
    HQC
    Regulation Number
    886.4670
    Why did this record match?
    Applicant Name (Manufacturer) :

    PARADIGM MEDICAL INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Paradigm Phaco Tip is intended to be used in conjunction with an ultrasonic handpiece for ophthalmic surgery to remove cataract tissue.
    Device Description
    Not Found
    Ask a Question
    K Number
    K971795
    Device Name
    AUTOMATED CHAMBER MAINTENANCE MODULE
    Manufacturer
    PARADIGM MEDICAL INDUSTRIES, INC.
    Date Cleared
    1997-07-14

    (60 days)

    Product Code
    HQC
    Regulation Number
    886.4670
    Why did this record match?
    Applicant Name (Manufacturer) :

    PARADIGM MEDICAL INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ACM Module is an accessory device incorporated in the aspiration line behind the handpiece to neutralize vacuum surge during phacoemulsification.
    Device Description
    Not Found
    Ask a Question
    K Number
    K970887
    Device Name
    BLOOD FLOW ANALYZER
    Manufacturer
    PARADIGM MEDICAL INDUSTRIES, INC.
    Date Cleared
    1997-06-17

    (98 days)

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

    PARADIGM MEDICAL INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A tonometer and acsessories are devices intended to measure intraocular pressure by applying a known force on the globe of the eye to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. We intend the device for use in the diagnosis of glaucoma.
    Device Description
    A tonometer and accessories are devices intended to measure intraocular pressure by applying a known force on the globe of the eye to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. We intend the device for use in the diagnosis of glaucoma.
    Ask a Question

    Page 1 of 1