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510(k) Data Aggregation
K Number
K162636Device Name
Marco Ultra M3, Marco Ultra M4
Manufacturer
Date Cleared
2017-04-14
(205 days)
Regulation Number
886.1850Why did this record match?
Applicant Name (Manufacturer) :
TAKAGI SEIKO CO.LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
An AC-powered slit-lamp biomicroscope and accessories intended for use in the 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 traumas which affect the structural properties of the anterior eye segment.
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 a patient's eye through a control diaphragm a thin, intense beam of light.
The slit lamp illumination is composed of the light source, the slit, collimation and imaging optics, and infrared and ultra violet filters and a dielectric mirror. The slit lamp have the option to combine a background illumination together with the slit illumination.
The patient sits in front of the slit lamp with his chin rest and his forehead against the forehead band. The chin rest is adjusted in height until the eyes of the patient are level with the black mark of the headrest column. The light is switched on and the brightness is controlled with a knob on the power supply. With the joystick 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. 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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