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Refractometer, Ophthalmic
FDA product code HKO · Class 1 · Ophthalmic
170
Registered devices
173
Adverse events
5
Recalls
35
510(k) clearances
Devices with this code
Righton — RIGHT MFG. CO., LTD.Rexxam — REXXAM CO., LTD.Open-field Refraction System — NIDEK CO.,LTD.Righton — RIGHT MFG. CO., LTD.RODENSTOCK — LUNEAU TECHNOLOGY OPERATIONSplusoptiX 12 — Plusoptix GmbHWelch Allyn, Inc. — WELCH ALLYN, INC.Microclear — Suzhou Microclear Medical Instruments Co., Ltd.Auto Ref/Keratometer HRK-8100A — Huvitz Co., Ltd.Righton — RIGHT MFG. CO., LTD.GoCheck MultiScreener — Gobiquity, Inc.VISIONIX — LUNEAU TECHNOLOGY OPERATIONSRef/Keratometers HRK-7000 — Huvitz Co., Ltd.AKR 800 — ESSILOR INTERNATIONALGoCheck Kids — Gobiquity, Inc.Eli Ezer — U.S. OPHTHALMIC, L.L.C.VISIONIX — LUNEAU TECHNOLOGY OPERATIONSPark 1 — OCULUS Optikgeräte Gesellschaft mit beschränkter HaftungESSILOR — LUNEAU TECHNOLOGY OPERATIONSAUTO KERATO-REFRACTOMETER KR-800PA — TOPCON CORPORATIONAUTO KERATO-REFRACTOMETER KR-800A — TOPCON CORPORATIONRighton — RIGHT MFG. CO., LTD.Remidio — REMIDIO INNOVATIVE SOLUTIONS PRIVATE LIMITEDplusoptiX 16 — Plusoptix GmbH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-02-18 | Baxter Healthcare Corporation | Display screen may unintentionally flicker due to a software issue. Exposure to flickering lights may induce photosensitive seizure activity in susceptible indi |
| 2020-08-06 | Carl Zeiss Meditec AG | Due to the incorrect DC/DC converter being assembled onto the communication board. As a result the effectiveness of the communication board cannot be guarantee |
| 2017-12-20 | Nidek Inc. | There is possibly a difference between the measured dioptric value of the subjective measurement mode and the objective measurement mode on ARK-1s. |
| 2015-06-15 | Nidek Inc | 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. |
| 2012-12-05 | Canon Inc. | Canon Inc. had received 17 claims from our foreign sales companies between October to November 2012 that measurement value of RK-F2s refractive power (SPH value |
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