Kowa DR-1α
The Kowa DR-1α is an ocular surface interferometer used by a physician to observe and record tear film images in adult patients. It illuminates the tear film with white light and captures…
The Kowa DR-1α is an ocular surface interferometer used by a physician to observe and record tear film images in adult patients. It illuminates the tear film with white light and captures the resulting interference pattern as video for visual monitoring and documentation.
Its optical arrangement uses two parallel polarizers to capture reflected illumination while excluding external light. This allows the tear film interference image to be observed without the iris and sclera appearing as background structures.
Listed Item
The KOWA DR-1α is an ocular surface interferometer, which is an ophthalmic imaging device that is intended for use by physician in adult patients to observe and record a video image of specular (interferometric) observations of the tear film, which can be visually monitored and photographically documented.
Review and Export
Recorded video can be replayed on the instrument’s monitor. The user can select two time points to measure an interval and can export video or a still image taken from the recording to an external computer.
Who Else Makes It
Concentrated in Jiangsu (1), Shanghai (1), Chongqing (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Mediworks Precision Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 13 |
| Taizhou City K&W International Trade Co., Ltd. | Jiangyan | Jiangsu | Repacker / relabeller | 38 |
| Chongqing BIO Newvision Medical Equipment Ltd. | Chongqing | Chongqing | Manufacturer | 2 |
Record
| Listed by | Kowa Co., Ltd., Japan |
|---|---|
| FDA product code | HKI |
| Device type | Camera, Ophthalmic, Ac-Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 886.1120 |
| 510(k) | K190573 |
| Record published | 2019-06-10 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Storage environment temperature -10 to 55 °C; Storage environment humidity 10 to 95 % RH; Storage environment atmospheric pressure 70 to 106 KiloPascal; Handling environment humidity 30 to 90 % RH; Handling environment atmospheric pressure 80 to 106 KiloPascal; Handling environment temperature -10 to 35 °C |
| Distribution end date | 2019-06-10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DE2K | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Jedmed | Jedmed Instrument Company | 15 |
| Neolight | Neolight, LLC | 11 |
| Natus | Xltek | 6 |
| RetCam Envision | Natus Medical Denmark ApS | 6 |
| 3nethra | Forus Health Pvt.ltd., | 6 |
| iCam | Optovue, Inc. | 5 |
| iFusion | Optovue, Inc. | 5 |
| Canon Inc. | Canon Inc. | 4 |
| Camera, Ophthalmic, Ac-Powered | Chongqing Kanghuaruiming S&T Co., Ltd.. | 4 |
| 3D Optical Coherence Tomography 3D OCT-1(Type:Maestro2) | Topcon Corp. | 3 |
| Retinal Camera TRC-50DX | Topcon Corp. | 3 |
| NON-Mydriatic Retinal Camera TRC-NW400 | Topcon Corp. | 2 |
Showing 12 of 123. All products under Camera, Ophthalmic, Ac-Powered
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K191945 | 2019-09-10 |
| K190573 | 2019-06-04 |
| K112330 | 2012-02-16 |
| K101628 | 2011-01-26 |
| K091098 | 2009-08-07 |
| K091683 | 2009-07-02 |
| K083387 | 2009-01-16 |
| K082767 | 2008-10-21 |
| K080681 | 2008-04-04 |
| K062021 | 2006-11-01 |
| K062356 | 2006-09-27 |
| K053026 | 2005-11-10 |
| K050271 | 2005-11-03 |
| K043213 | 2005-10-06 |
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.