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510(k) Data Aggregation
K Number
K181143Device Name
Keeler TonoCare Tonometer
Manufacturer
Keeler Instruments Inc.
Date Cleared
2019-02-08
(283 days)
Product Code
HKX
Regulation Number
886.1930Why did this record match?
Applicant Name (Manufacturer) :
Keeler Instruments Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Keeler TonoCare Tonometer is a hand-held, battery operated, non-contact tonometer intended to be used for measuring intraocular pressure (IOP) of the human eye with less than 3D in corneal astigmatism.
Device Description
The Keeler TonoCare Tonometer is designed to measure Intra Ocular Pressure (IOP) to aid in the screening and diagnosis of glaucoma without contacting the eye. The Keeler TonoCare Tonometer has been designed using the same ergonomics as the predicate device described in 510(k) submission K093298. Both products consist of an air generation system in the form of a vacuum Diaphragm pump, an air reservoir, a solenoid valve, a light source and an opto-electronic platform which is used for position detection and IOP measurement. The basic concept of operation is the same. The user positions the instrument close to the patient's cornea using a targeting system. As the user moves the instrument closer to the patient, the reflection off the cornea from the built-in light source increases until the predefined firing thresholds on the built-in photodiodes have been met. Once this condition has been met, a quantized puff of air is automatically projected toward the patient's cornea. As the cornea flattens due to the force of the puff of air, the light being reflected off of the cornea changes shape which in turn changes the profile of the light being reflected back onto the photodiodes. The rate of change of this reflection is monitored by the photodiodes and converted into intraocular pressure in units of mmHg by the on-board microprocessor.
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