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510(k) Data Aggregation
K Number
K071755Device Name
FALCK APPLANATION TONOMETER (FAT2)
Manufacturer
Date Cleared
2008-06-03
(341 days)
Regulation Number
886.1930Why did this record match?
Applicant Name (Manufacturer) :
FALCK MEDICAL INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Falck Medical Applanation Tonometer Model 2 (FAT 2) is indicated in the measurement of intraocular pressure and ocular pulsatile amplitude.
Device Description
The Falck Medical Applanation Tonometer (FAT 2) measures the intraocular pressure by applanation of the cornea uses a disposable sterile plastic prism. It is used as an accessory to a slit lamp microscope. Internal software is used for error checking and calibration. The disposable prism is mounted on a free floating counterweighted arm. When the prism comes into contact with the cornea, the initial applanation area is determined by the biomechanics of the cornea. Force is then actively applied to the cornea and measurements are taken every 13.8 milliseconds. Multiple readings are taken and statistical analysis is performed to ensure repeatability. The measurement principle is the same as the Goldmann, but adjustments are reade for variations in surface wetness and corneal resistance. The size of the applanation area is objectively determined by using visible light and the principle of total internal reflectance (TIR). A new sterile disposable prism is required prior to each new patient. In addition to intraocular pressure, the device also measures ocular pulsatile amplitude by recording the change in the applanation signal that occurs with the cardiac cycle. The measurement of ocular pulsatile amplitude is similar to the Langham methodology.
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