Home › Ningbo Ming Sing Optical R & D Co., Ltd. › AUTO REF/KERATOMETER

AUTO REF/KERATOMETER

Ningbo Ming Sing Optical R & D Co., Ltd. · Model ARK-910 · UDI-DI 06971821402127

HKO Prescription

510(k) clearances

178

Adverse events

Recalls

Facilities

Description

Structure: composed of optical imaging system, control system and display. Working principle: AUTO REF/KERATOMETER is to use infrared fundus reflex phase method, by launching a specific wavelength beam of infrared light, through the examiner cornea, lens and so on, finally projected onto the retina eyeball, then reflected back to the corresponding optical system, absorb the image by image sensor, after image processing, signal processing, calculate the ball lens diopter, axial column lens dioptre, column mirror, An instrument used to determine the refractive state of the human eye. AUTO REF/KERATOMETER can move in X axis, Y axis and Z axis at the same time, with 3D automatic eye tracking function.

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 individuals.
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 guaranteed in that the safety
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) sometimes indicate

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.