Auto Refractometer
The NIDEK AUTO REFRACTOMETER AR-1s measures spherical, cylindrical refractive errors, and cylinder axis from the refractive status of the patient’s eye. In addition, subjective test is…
The NIDEK AUTO REFRACTOMETER AR-1s measures spherical, cylindrical refractive errors, and cylinder axis from the refractive status of the patient’s eye. In addition, subjective test is performed with the built-in charts and lenses for subjective measurement.
Who Else Makes It
Concentrated in Jiangsu (4), Shanghai (4), Beijing (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Wuxi Zontai Int’l Corporation Ltd. | Wuxi | Jiangsu | Contract manufacturer | 22 |
| Taiyuan North China Xinyuan Tech. Center (Co., Ltd.) | Taiyuan | Shaanxi | Contract manufacturer | 14 |
| Beijing Hongdee Corporation | Beijing | Beijing | Private-label distributor | 43 |
| Taizhou City K&W International Trade Co., Ltd. | Jiangyan | Jiangsu | Repacker / relabeller | 38 |
| Lianyungang Tiannuo Optical Instrument Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 31 |
| Shanghai Link Instruments Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 21 |
| Gino Optical (Shanghai) Co., Ltd. | Shanghai | Shanghai | Manufacturer | 15 |
| Shanghai Mediworks Precision Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 13 |
| Chongqing Sunkingdom Medical Instrument Co., Ltd. | Chongqing | Chongqing | Manufacturer | 11 |
| Ningbo Ming Sing Optical R&D Co., Ltd. | Ningbo | Zhejiang | Repacker / relabeller | 9 |
| Shenzhen Certainn Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 7 |
| Chongqing Yeasn Science-Technology Co., Ltd. | Chongqing | Chongqing | Contract manufacturer | 5 |
Showing 12 of 17. All 17 manufacturers in China registered for Refractometer, Ophthalmic
Record
| Listed by | Nidek Incorporated, United States |
|---|---|
| FDA product code | HKO |
| Device type | Refractometer, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1760 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-04-20 |
| Record revised | 2020-12-21 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AR-1a | In distribution | |
| AR-F | In distribution | |
| AR-1s | In distribution | |
| AR-1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Righton | Right MFG. Co., Ltd. | 27 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 13 |
| Visionix | Right MFG. Co., Ltd. | 13 |
| Auto REF/Keratometer | Ningbo Ming Sing Optical R&D Co., Ltd. | 6 |
| Microclear | Suzhou Microclear Medical Instruments Co., Ltd. | 6 |
| Rexxam | Rexxam.co., Ltd. | 5 |
| plusoptiX 12 | Plusoptix Gmbh | 4 |
| Auto Refkeratometer | Tomey Corporation | 4 |
| MediWorks | Shanghai Mediworks Precision Instruments Co., Ltd. | 3 |
| Auto Refractometer RM-800 | Topcon Corp. | 3 |
| Yeasn | Chongqing Yeasn Science-Technology Co., Ltd. | 3 |
| Auto REF/Keratometer | Nidek Incorporated | 3 |
Showing 12 of 52. All products under Refractometer, Ophthalmic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K902500 | 1990-07-27 |
| K901513 | 1990-06-08 |
| K890559 | 1989-02-27 |
| K882191 | 1988-07-01 |
| K861065 | 1986-04-09 |
| K861062 | 1986-04-04 |
| K861066 | 1986-04-04 |
| K831083 | 1983-06-10 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2017-12-20 | Class II | Equipment maintenance | There is possibly a difference between the measured dioptric value of the subjective measurement mode and the objective measurement mode on ARK-1s. | 63 untis | 2019-03-18 |
| 2015-06-15 | Class II | Software design | Software bug was found where there was no difference in Total and Corneal high-order aberrations, but differences were found in Internal high-order aberrations. | 3836 | 2016-04-25 |
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.