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510(k) Data Aggregation
K Number
K052674Device Name
CONTACT LENS OPHTHALMODYNAMOMETER
Manufacturer
Date Cleared
2006-05-24
(239 days)
Regulation Number
886.1385Why did this record match?
Product Code :
NYK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The device is indicated for examination of the ocular fundus, vitreous and retinal structures, while manually applying force to the eye with the contact lens. The device measures and displays the amount of force that is applied to the eye.
Device Description
The Meditron Contact Lens Ophthalmodynamometer is a classic Goldmann three-mirror examination contact glass that has been adapted with precision electronic sensors for continuous measurement of pressure applied to the eye. Electronic signals from the sensors are used to determine pressure values, which are then displayed on the device's LCD display.
The patient contact portion of the examination glass consists of a curved shell of acrylic plastic (PMMA) that is applied for a short period of time directly on the globe or cornea of the eye. PMMA is commonly used as a material in examination contact glasses having the same intended purpose.
The mirror angles are the same as the original Goldmann and predicate devices: 59/66/73 degrees.
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