BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Park 1

    DI: 04049584000217 · Model: 65000 · OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Park 1
    Primary DI
    04049584000217
    Version / Model
    65000
    Company Name
    OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
    Labeler DUNS
    317138956
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-01
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    a40ea847-b377-47c1-978d-43101bcca848

    Device Description

    The PARK 1 combines three measuring functions in one unit. Auto-Refractometer An infrared light source projects measuring light onto the retina of the eye from where it is reflected back to the shutter location. Sensitive sensor chips, or CCD cameras now register the deviation of the reflected light from the shutter location. The deviation depends on the ametropia. From that, an integrated microcomputer calculates the ametropia in D, based on the sphere, cylinder and cylinder axis position. 1 Measuring ocular / Patient eyepiece 4 Chin rest 2 Keratometer ring 5 Marking for the eye height 3 Pachycam camera glass cover Keratometer To determine the curvature of the cornea, a reflected image of the cornea is 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. Pachymeter The pachymetry principle uses Scheimpflug images of the cornea, which are analysed by a built-in computer. 600 Absolute data points are evaluated with the Scheimpflug image. The measuring range lies on a 4 mm slit through the apex. The slit light illuminates a sectional plane from the front surface of the cornea to the back surface. The transparent cells of the cornea scatter the slit light 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, whereby the image plane of the camera is also tilted 45° to the optical axis of the camera lens, in order to sharply focus the light-scattering cornea plane onto the image plane of the camera (Scheimpflug image). Thanks to this arrangement, sharp sectional images of the cornea can be attained.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    Yes

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HLQ Keratoscope, Ac-Powered
    HKO Refractometer, Ophthalmic
    MXK Device,Analysis,Anterior Segment

    GMDN Terms

    Code Name
    36387 Ophthalmic refractometer, manual

    Identifiers

    Type ID
    Primary 04049584000217

    Premarket Submissions

    Submission Number Supplement Number
    K073508 000

    Device Sizes

    Type Value Unit Text
    Weight 12 Kilogram
    Depth 530 Millimeter
    Width 538 Millimeter
    Height 265 Millimeter

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -10 – 70 Degrees Celsius
    Type
    Storage Environment Humidity
    Temperature Range
    10 – 75 Percent (%) Relative Humidity
    Type
    Storage Environment Atmospheric Pressure
    Temperature Range
    50 – 106 KiloPascal
    Type
    Handling Environment Temperature
    Temperature Range
    10 – 40 Degrees Celsius
    Type
    Handling Environment Humidity
    Temperature Range
    30 – 75 Percent (%) Relative Humidity
    Type
    Handling Environment Atmospheric Pressure
    Temperature Range
    70 – 106 KiloPascal