Park 1

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…

Registry build 21.09.26

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.

2manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

All of them in Jiangsu.

Chinese manufacturers registered for FDA product code HLQ
Manufacturer City Province Registered as Device types
Taizhou City K&W International Trade Co., Ltd. Jiangyan Jiangsu Repacker / relabeller 38
Lianyungang Tiannuo Optical Instrument Co., Ltd. Lianyungang Jiangsu Contract manufacturer 31

Record

Regulatory record for Park 1
Listed by Oculus Optikgeräte Gesellschaft mit beschränkter Haftung
FDA product code HLQ
Device type Keratoscope, Ac-Powered
Device class Class 1
Regulation 21 CFR 886.1350
510(k) K073508
Record published 2016-09-01
Record revised 2018-07-06 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries serial number
Storage Storage environment temperature -10 to 70 °C; Storage environment humidity 10 to 75 % RH; Storage environment atmospheric pressure 50 to 106 KiloPascal; Handling environment temperature 10 to 40 °C; Handling environment humidity 30 to 75 % RH; Handling environment atmospheric pressure 70 to 106 KiloPascal
Sizes Weight 12 kg; depth 530 mm; width 538 mm; height 265 mm

Catalogue Numbers

Catalogue numbers for Park 1
Catalogue number Size Status
65000 Weight 12 kg In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Auto REF/Keratometer Nidek Incorporated 2
Tiannuo / Tnmed Lianyungang Tiannuo Optical Instrument Co., Ltd. 2
Ibex Keratometer Trevi Technology 1
Refractive Power / Corneal Analyzer Nidek Incorporated 1
Leica Keratoscope Leica Microsystems (Schweiz) AG 1
Medmont Corneal Topographer E300 USB Medmont International PTY Ltd 1

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer