LogoFDA 510(k) Search
Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K980924
    Device Name
    PLANCON MICROLAMELLAR KERATOME EVOLUTION
    Manufacturer
    PLANCON INSTRUMENTS
    Date Cleared
    1998-04-15

    (35 days)

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

    PLANCON INSTRUMENTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended for use in refractive surgery, to perform , microlamellar keratoplasty or keratomileusis in-situ for the correction of myopia and hyperopia.
    Device Description
    The submitted device system composition includes: Power unit, Turbine motor, Fixed keratome head, Keratome blade, Pneumatic fixation rings, Applanation lenses. The power unit includes: Vacuum pump, Battery, Vacuum release valve, Knob to regulate gas pressure, Gas & vacuum pressure gauges, Vacuum & turbine quick connectors, Battery charger unit. The turbine motor is gas powered with adjustable speed 0 to 20 000 RPM (recommended 14 000 RPM), made of stainless steel, titanium and aluminium, with no gear system. The keratome is made of stainless steel with a fixed single piece head and safety allowing only one cut depth. Pneumatic fixation rings are made of stainless steel with double dovetails. Applanation lenses are made of clear plastic + stainless handle with engraved inner reticle diameter.
    Ask a Question
    K Number
    K970377
    Device Name
    PLANCON MICROLAMELLAR KERATOME (SINGLE PIECE KERATOME HEAD WITH ACCESSORIES)
    Manufacturer
    PLANCON INSTRUMENTS
    Date Cleared
    1997-03-31

    (56 days)

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

    PLANCON INSTRUMENTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To perform microlamellar keratoplasty for the correction of myopia or hyperopia
    Device Description
    Power unit, Turbine motor, Fixed keratome head, Keratome blade, Pneumatic fixation rings, Applanation lenses
    Ask a Question
    K Number
    K960395
    Device Name
    PLANCON MIRCOLAMELLAR KERATOME
    Manufacturer
    PLANCON INSTRUMENTS
    Date Cleared
    1996-04-26

    (88 days)

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

    PLANCON INSTRUMENTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To perform microlamellar keratoo asty for the correction of myopia or hyperopia
    Device Description
    Power urit Turbine motor Adjustable keratome head Keratome blade Pneumatic fixation rings Applanation lenses Plate check ng gauge
    Ask a Question

    Page 1 of 1