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510(k) Data Aggregation
K Number
K062930Device Name
LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM
Manufacturer
ALCON RESEARCH, LTD.
Date Cleared
2006-11-08
(41 days)
Product Code
NCF
Regulation Number
886.1760Why did this record match?
Product Code :
NCF
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LADARWave® CustomCornea® Wavefront System is used for measuring, recording, and analyzing visual aberrations (such as myopia, astigmatism, coma and spherical aberration) and for displaying refractive error maps of the eye to assist in prescribing refractive corrections.
This device is enabled to export wavefront data and associated anatomical registration information to a compatible treatment laser where a wavefront-guided treatment is indicated.
This device can also export centration data and associated registration information for conventional phoropter-based refractive surgery with the LADAR6000™ System.
Device Description
The LADARWave® CustomCornea® Wavefront System is an aberrometer, utilizing Hartmann-shack wavefront sensing to measure the aberrations in the human eye. The device contains four major optical subsystems used in the clinical wavefront examination.
- A fixation subsystem provides the patient with an unambiguous point of fixation. . Optics in this path automatically adjusts to correct for the patient's spherocylindrical error so that the target is clearly observed.
- A video subsystem provides the device operator with a view of the eye at the . measurement plane. The operator uses the video imagery to position the eye for the measurement and to record the geometry of the wavefront relative to anatomical features.
- A probe beam subsystem directs a narrow beam of eye-safe infrared radiation . into the eye to generate the re-emitted wavefront.
- A wavefront detection subsystem images the re-emitted wavefront onto the . entrance face of the Hartmann-shack wavefront sensor.
These subsystems are all under control of the device software.
Once the wavefront examination is complete, the operator may export the exam data to removable media. The exported electronic file contains all information necessary to perform customized ablative surgery using either the LADARVision®4000 or LADAR6000" System. The information includes the wavefront measurement, essential patient identification information, and geometric registration data. The electronic file is in a proprietary format and is encrypted so that wavefront data cannot be exported for use by an incompatible treatment device.
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K Number
K050336Device Name
OPD-STATION SOFTWARE
Manufacturer
NIDEK, INC.
Date Cleared
2005-08-24
(195 days)
Product Code
NCF, MMQ
Regulation Number
886.1760Why did this record match?
Product Code :
NCF
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OPD-Station software is indicated for use in analyzing the corneal shape and refractive powers measured by the OPD-Scan Models ARK-9000 or ARK-10000, and to display the data in the form of maps, and manage the data.
Device Description
Nidek has developed a stand-alone software option for users of the OPD-Scan™ device called OPD-Station, which will run on an independent PC (i.e., separate from the OPD-Scan™ device). The OPD-Station software is able to access data measured by the OPD-Scan™ device via a separate Nidek data management software package called NAVIS.
The OPD-Station uses the same software as that used for the OPD-Scan device so that a physician can view OPD-Scan data on their PC of choice. However, the OPD-Station software has the following new functions:
- Maps of Point Spread Function (PSF), Modulation Transfer Function (MTF), MTF . graphing, and Visual Acuity mapping
- Improved color mapping .
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K Number
K023249Device Name
ALCON LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM
Manufacturer
ALCON LABORATORIES, INC.
Date Cleared
2002-10-18
(18 days)
Product Code
NCF
Regulation Number
886.1760Why did this record match?
Product Code :
NCF
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LADARWave" CustomCornea® Wavefront System is used for measuring, recording, and analyzing visual aberrations (such as myopia, hyperopia, astigmatism, coma and spherical aberration) and for displaying refractive error maps of the eye to assist in prescribing refractive corrections. This device is enabled to export wavefront data and associated anatomical registration information to a compatible treatment laser with an indication for wavefront-guided refractive surgery.
Device Description
The LADARWave" CustomCornea® Wavefront System is an aberrometer, utilizing Hartmann-Shack wavefront sensing to measure the aberrations in the human eye. The device contains four major optical subsystems used in the clinical wavefront examination: a fixation subsystem, a video subsystem, a probe beam subsystem, and a wavefront detection subsystem. These subsystems are all under control of the device software.
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K Number
K000637Device Name
CUSTOMCORNEA MEASUREMENT DEVICE (CCMD)
Manufacturer
ALCON LABORATORIES, INC.
Date Cleared
2000-05-19
(84 days)
Product Code
NCF
Regulation Number
886.1760Why did this record match?
Product Code :
NCF
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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