Park 1

Primary DI
04049584000217
Brand
Park 1
Company
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
Model
65000
Device description
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.
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HKORefractometer, Ophthalmic
HLQKeratoscope, Ac-Powered
MXKDevice,Analysis,Anterior Segment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HKORefractometer, OphthalmicOphthalmic1
HLQKeratoscope, Ac-PoweredOphthalmic1
MXKDevice, Analysis, Anterior SegmentOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K073508000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K073508000PARKONEOculus Optikgerate GmbH2008-09-11MXK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049584000217PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049584000217040495840002174049584000217

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic refractometer, manualA manually-operated ophthalmic device used to measure the refractive error of the eye (the inaccuracies of focusing of light upon the retina); typically the measurements are made in dioptres (the reciprocal of the focal length of the lens expressed in metres). Using this information the optometrist can calculate the lens prescription needed to correct the patient's refractive error. With advanced instruments the measurements are made automatically with printed verification.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth530Millimeter
Height265Millimeter
Weight12Kilogram
Width538Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
317138956
Device count
1
Serial number
true
Donation ID number
true

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Primary DI, Brand, Model table
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04049584037718Precision Mount for B&L100394002026-01-23
04049584037725Precision Mount for Leica100390582026-01-23
04049584037732Precision Mount for Alcon100291772026-01-23
04049584037749Precision Mount for Zeiss100392342026-01-23
04049584037756Precision Mount for Haag Streit100291782026-01-23
04049584035714BIOM 6 HD Optic Set for f=175 mm100299002026-01-14
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04049584035738BIOM 6 HD Optic Set for f=175 mm100299002026-01-14
04049584035745BIOM 6 HD Optic Set for f=200 mm100299022026-01-14
04049584037152BIOM 6100348202026-01-14
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