Duns Number:317138956
Device Description: The PARK 1 combines three measuring functions in one unit.Auto-RefractometerAn infrared li The PARK 1 combines three measuring functions in one unit.Auto-RefractometerAn infrared light source projects measuring light onto the retina of the eyefrom where it is reflected back to the shutter location. Sensitive sensorchips, or CCD cameras now register the deviation of the reflected light fromthe shutter location. The deviation depends on the ametropia. From that, anintegrated microcomputer calculates the ametropia in D, based on thesphere, cylinder and cylinder axis position.1 Measuring ocular / Patient eyepiece 4 Chin rest2 Keratometer ring 5 Marking for the eye height3 Pachycam camera glass coverKeratometerTo determine the curvature of the cornea, a reflected image of the corneais captured by a camera sensor and is measured.The reflection of test marks and of a ring is used as the reflected image.This allows the central radii of the cornea to be determined.PachymeterThe pachymetry principle uses Scheimpflug images of the cornea, whichare analysed by a built-in computer.600 Absolute data points are evaluated with the Scheimpflug image. Themeasuring range lies on a 4 mm slit through the apex.The slit light illuminates a sectional plane from the front surface of the corneato the back surface. The transparent cells of the cornea scatter the slitlight such that the sectional plane appears as if it were self-luminous.This is captured at an angle of 45° through the pupil by a camera, wherebythe image plane of the camera is also tilted 45° to the optical axis of thecamera lens, in order to sharply focus the light-scattering cornea planeonto the image plane of the camera (Scheimpflug image).Thanks to this arrangement, sharp sectional images of the cornea can be attained.
Catalog Number
-
Brand Name
Park 1
Version/Model Number
65000
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
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For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K073508
Product Code
HKO
Product Code Name
Refractometer, Ophthalmic
Public Device Record Key
a40ea847-b377-47c1-978d-43101bcca848
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 01, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 4 |
2 | A medical device with a moderate to high risk that requires special controls. | 7 |