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Refractometer, Ophthalmic
FDA product code HKO · Class 1 · Ophthalmic
173
Registered devices
179
Adverse events
5
Recalls
35
510(k) clearances
Devices with this code
YEASN — Chongqing Yeasn Science & Technology Co.,Ltd.VISIONIX — LUNEAU TECHNOLOGY OPERATIONSGoCheck Kids — Gobiquity, Inc.REFRACTIVE POWER / CORNEAL ANALYZER — NIDEK CO.,LTD.YEASN — Chongqing Yeasn Science & Technology Co.,Ltd.Ref-Keratometer HRK-1 — Huvitz Co., Ltd.Welch Allyn, Inc. — WELCH ALLYN, INC.Remidio — REMIDIO INNOVATIVE SOLUTIONS PRIVATE LIMITEDWelch Allyn, Inc. — WELCH ALLYN, INC.Righton — RIGHT MFG. CO., LTD.VISIONIX — LUNEAU TECHNOLOGY OPERATIONSRexxam — REXXAM CO., LTD.Chinrest CRX-1000 for REFRACTION SYSTEM Chronos — TOPCON CORPORATIONVISIONIX — LUNEAU TECHNOLOGY OPERATIONSAUTO REFKERATOMETER — TOMEY CORPORATION.TIANNUO / TNMED — Lianyungang Tiannuo Optical Instrument Co., Ltd.Righton — RIGHT MFG. CO., LTD.REFRACTION SYSTEM Chronos — TOPCON CORPORATIONIwavePhoropter — Krypton Vision (Suzhou) Ltd.Kerato refractometer — CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDAUTO KERATO-REFRACTOMETER KR-1 — TOPCON CORPORATIONRighton — RIGHT MFG. CO., LTD.Righton — RIGHT MFG. CO., LTD.Eli Ezer — U.S. OPHTHALMIC, L.L.C.
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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