Panels › Ophthalmic › Product code HKO · Class 1
Refractometer, Ophthalmic
Regulation 886.1760
0510(k)s in 12 months (35 all time)
1recalls in 12 months (5 all time)
0recalls that name a 510(k)
Top companies in HKO
| Company | 510(k)s | Recalls |
|---|---|---|
| Nidek, Inc. | 8 | 2 |
| Canon USA, Inc. | 5 | 1 |
| American Optical Corp. | 3 | 0 |
| Stereo Optical Co., Inc. | 3 | 0 |
| Bausch & Lomb, Inc. | 2 | 0 |
| R.H. Burton Co. | 2 | 0 |
| Allergan Humphrey | 1 | 0 |
| Baxter Healthcare Corporation | 0 | 1 |
| Cannon U.S.A., Inc. | 1 | 0 |
| Carl Zeiss Meditec AG | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 18, 2026 | Baxter Healthcare Corporation Brand Name: Welch Allyn, Inc.
Product Name: Welch Allyn Spot Vision Screener VS100
Model/Catalog Number: VS100
Software Version: Software version 3.2.0.1
Product Description: Welch Allyn Spot Vision S Open, Classified |
HKO | None listed |
| Aug 6, 2020 | Carl Zeiss Meditec AG Carl Zeiss Meditec AG VISUREF150 REF 2227-967 - Product Usage: is a diagnostic instrument used to determine the objective refractive values and keratometric characteristics of the human eye. The resul Terminated |
HKO | None listed |
| Dec 20, 2017 | Nidek Inc. AUTO REF/KERATOMETER ARK-1s Terminated |
HKO | None listed |
| Aug 27, 2015 | Nidek Inc OPD-Scan III Refractive Power/Corneal Analyzer Opthalmic
Software versions 1.00.08 1.05.07 1.10.01, 1.01.02 1.06.02 1.11.02, 1.02.01 1.07.01 1.12.03, 1.03.02 1.08.01 1.13.01, 1.04.03 1.09.01.
Opthal Terminated |
HKO | None listed |
| May 25, 2013 | Canon Inc. Canon Full Auto Ref-Keratometer RK-F2, Catalog Number 6937B002AA.
Product Usage: This device is intended to be used to measure the refractive power and the radius of corneal curvature of the human e Terminated |
HKO | None listed |
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