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510(k) Data Aggregation

    K Number
    K063104
    Device Name
    FOX MEDICAL DIODE LASER SYSTEM 810NM
    Manufacturer
    HOWARD INSTRUMENTS, INC.
    Date Cleared
    2007-05-16

    (279 days)

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

    HOWARD INSTRUMENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The A.R.C. Laser Fox Laser System is indicated for retinal and pan retinal photocoagulation, endophotocoagulation and transcleral cyclophotocoagulation for the treatment of: Diabetic Retinopathy Retinal tears and detachment Age related macular degeneration Retinopathy of prematurity Primary open angle glaucoma Refractory glaucoma
    Device Description
    Not Found
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    K Number
    K030948
    Device Name
    VMATE MODEL VMM1000
    Manufacturer
    HOWARD INSTRUMENTS, INC.
    Date Cleared
    2003-06-17

    (83 days)

    Product Code
    HQE
    Regulation Number
    886.4150
    Why did this record match?
    Applicant Name (Manufacturer) :

    HOWARD INSTRUMENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    An electrically powered ophthalmic device intended to remove vitreous matter from the vitreous cavity
    Device Description
    An electrically powered ophthalmic device intended to remove vitreous matter from the vitreous cavity
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    K Number
    K980985
    Device Name
    SCMD-1000
    Manufacturer
    HOWARD INSTRUMENTS, INC.
    Date Cleared
    1998-05-01

    (45 days)

    Product Code
    HNO
    Regulation Number
    886.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    HOWARD INSTRUMENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SCMD-1000 blades are to be used with the SCMD Microkeratome.
    Device Description
    Not Found
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    K Number
    K974598
    Device Name
    MICROKERATOME OR THE MATE
    Manufacturer
    HOWARD INSTRUMENTS, INC.
    Date Cleared
    1998-04-22

    (134 days)

    Product Code
    HNO
    Regulation Number
    886.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    HOWARD INSTRUMENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MMK-1000 is designed to produce a corneal flap.
    Device Description
    Not Found
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    K Number
    K972727
    Device Name
    CBALK-1000 BLADE
    Manufacturer
    HOWARD INSTRUMENTS, INC.
    Date Cleared
    1997-10-10

    (81 days)

    Product Code
    HNO
    Regulation Number
    886.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    HOWARD INSTRUMENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CBALK-1000 blades are to be used with the Chiron Microkeratome.
    Device Description
    CBALK-1000 Blades
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