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510(k) Data Aggregation
K Number
K981665Device Name
SILON TOPOMAT CORNEAL TOPOGRAPHY IMAGE ENHANCEMENT DEVICE
Manufacturer
BIO-MEDICAL SCIENCES, INC.
Date Cleared
1998-12-07
(210 days)
Product Code
MMQ
Regulation Number
886.1350Why did this record match?
Product Code :
MMQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For the measurement of the topographical surface of the cornea using rasterstereographic imaging techniques.
Device Description
The Silon Topomat device provides a convenient method of imaging the surface of the cornea with existing corneal topography apparatuses while avoiding the use of dves and wetting agents. The Silon Topomat device consists of a hydrophobic silicone-based membrane. It can accurately contour to irregular surfaces, closely following even minute topographical features. The membrane is fixed within two couplings as to provide a rigid ring structure in the form of a "drum-head" of approximately 13 millimeters in diameter. The ring has a gripping tab on one edge to facilitate handling and serve as an orientation reference. The membrane is applied against the surface of the cornea, and an accurate topographic image is obtained directly from the distal surface of the membrane using videokeratographic or rasterstereographic imaging techniques.
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K Number
K964702Device Name
EUCLID SYSTEMS CORNEAL TOPOGRAPHER MODEL ET800
Manufacturer
EUCLID SYSTEMS CORP.
Date Cleared
1997-05-20
(176 days)
Product Code
MMQ
Regulation Number
886.1350Why did this record match?
Product Code :
MMQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Corneal Topographer: Indicated for use for measuring the shape and curvature of the anterior surface of the eye and for displaying the topographical maps of the surface of the cornea. This information can be used to analyze, monitor and evaluate the shape and symmetry of the comea following refractive surgery, to assist in the diagnosis of keratoconus, to assist in the fitting of contact lenses, to assist in the understanding of various corneal irregularities such as those induced by post operative sutures and wounds, and to assist in the understanding of various refractive conditions of the cornea, such as myopia, hyperopia, and astigmatism.
Device Description
Not Found
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K Number
K964891Device Name
ORBSHOT KERATOMETER
Manufacturer
ORBTEK, INC.
Date Cleared
1997-03-26
(110 days)
Product Code
MMQ
Regulation Number
886.1350Why did this record match?
Product Code :
MMQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K963762Device Name
CORNEAL TOPOGRAPHER 200
Manufacturer
ECLIPSE VENTURES
Date Cleared
1996-12-23
(95 days)
Product Code
MMQ
Regulation Number
886.1350Why did this record match?
Product Code :
MMQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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