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510(k) Data Aggregation

    K Number
    K142179
    Device Name
    D-KAT Z-YPE
    Manufacturer
    KEELER LTD.
    Date Cleared
    2014-09-17

    (40 days)

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

    KEELER LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Z-type Digital Keeler Applanation Tonometer is indicated for measuring intraocular pressure to aid in the screening and diagnosis of Glaucoma.
    Device Description
    The Z-type Digital Keeler Applanation Tonometer is a screening device used to measure intraocular pressure which is one of the factors considered in diagnosing glaucoma. The product is an active medical device, powered by a single AA battery. The operation principal is based on Goldmann applanation method.
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    K Number
    K131787
    Device Name
    CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES
    Manufacturer
    KEELER LTD.
    Date Cleared
    2013-12-23

    (188 days)

    Product Code
    HRN, REV
    Regulation Number
    886.4170
    Why did this record match?
    Applicant Name (Manufacturer) :

    KEELER LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Keeler Cryomatic System and probes are for use in ophthalmic surgery such as cryopexy for retinal detachment, cyclo destructive procedures in refractory glaucoma, extraction of fragments within the vitreous cavity, cataract extraction, cryo destruction of lash follicles for trichiasis and treatment of retinopathy of prematurity (ROP).
    Device Description
    The Cryomatic MKII console is a self-contained system. The console consists of a rigid PU enclosure, housing the principle subsystems, switch mode power supply, controller PCB and pneumatic control module. On the front of the console is an LCD screen and membrane key panel. The console provides the connection point for the range of probe (reusable and disposable), footswitch, mains electricity, gas supply and scavenging system. There is a variety of Keeler Re-usable Cryomatic Probes whose stainless tips are shaped depending on surgical application. The plastic handle is permanently connected to flexible pressure hose and integral connector, which connects to Cryomatic MKII Console. The Keeler Disposable Cryo Probe comprises a stainless steel stem with a metal handle connected to a 2m long bi-lumen high-pressure plastic hose contained within a protective outer tube and terminated with a customdesigned plastic connector for insertion into the Cryomatic MKII console.
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    K Number
    K131589
    Device Name
    KEELER SLIT LAMP H-SERIES
    Manufacturer
    KEELER LTD.
    Date Cleared
    2013-06-27

    (27 days)

    Product Code
    HJO
    Regulation Number
    886.1850
    Why did this record match?
    Applicant Name (Manufacturer) :

    KEELER LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Keeler Slit Lamp is an AC-powered Slit lamp biomicroscope and is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affects the structural properties of the anterior eye segment This device is intended to be used only by suitably trained and authorised healthcare professionals.
    Device Description
    An AC-powered slit lamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into the patient's eye through a control diaphragm a thin, intense beam of light. This Keeler Slit Lamp has an XYZ translation base that is either mounted onto a custom table top supplied by Keeler or can be mounted on a third parties table top (refraction unit) by suitably trained technicians. Fitted to the XYZ base is the illumination and observation system; fitted to the table top is the chinrest assembly with fixation target. The illumination system rotates around its mounting axis and has a number of filters and graticules allowing the user to control precisely the characteristics of the examination light. The magnification body has a magnification change systems and eyepieces adjustable for the user's individual pupillary distance and distance correction. The patient is seated in front of the slit lamp with his/her chin in the chin rest and forehead against the forehead rest. The chin rest can be adjusted in height to align the eyes of the patient with the optics/light beam. With the control lever the instrument can be moved back and forward until the slit appears in focus on the cornea. The image can be observed through the microscope. The base unit has a rheostat to control the illumination level. Various magnifications can be selected on the microscope. For different observations the slit width can be changed, the slit can be tilted horizontally, and the angle between the illumination unit and the microscope can also be varied horizontally.
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    K Number
    K093445
    Device Name
    KEELER APPLANATION TONOMETER; T-TYPE KAT, K-TYPE KAT, (KAT)
    Manufacturer
    KEELER LTD.
    Date Cleared
    2010-01-19

    (90 days)

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

    KEELER LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Keeler Applanation Tonometer is indicated for measuring intraocular pressure to aid in the screening and diagnosis of Glaucoma.
    Device Description
    The Keeler Applanation Tonometer is a screening device used to measure intraocular pressure which is one of the factors considered in diagnosing glaucoma. The product is a non-active medical device and is completely mechanical, therefore without electrical components. The operation principal is based on Goldmann applanation method. The product is installed on a special support on the slit lamp and is used in conjunction with commercially available slit lamps.
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