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Multicolor Laser Photocoagulator

NIDEK CO.,LTD. · Model MC-500 · UDI-DI 04987669100080

HQF Prescription

510(k) clearances

1,534

Adverse events

Recalls

Facilities

Description

The NIDEK Multicolor Laser Photocoagulator MC-500 is a laser photocoagulator for ophthalmology with the light source of wavelengths 647, 577, and 532 nm. As the conventional laser photocoagulators, the MC-500 can be used for retinal photocoagulation for treatment of ocular fundus diseases like diabetic retinopathy, age-related macular degeneration, retinopathy of prematurity, and retinal detachment, or for laser iridotomy and laser trabeculoplasty for treatment of glaucoma. The device incorporates two types of lasers (diode-pumped solid state laser and laser diode) which enable efficient obtainment of laser beam oscillation of each wavelength. As the conventional device, various types of laser delivery units can be used. Therefore, transpupillary photocoagulation can be performed using various delivery units such as slit lamps and binocular indirect ophthalmoscope.

Recalls

Date	Firm	Reason
2025-12-05	Beaver-Visitec International, Inc.	Manufacturing deviation in which the ferrites specified for the USB cable assembly linking the Nurse Monitor touchscreen to the System Controller were not installed as intended. Th
2023-03-16	Ellex Medical Pty Ltd.	When using a Laser-Indirect-Ophthalmoscope (LIO) as the delivery device, a scattered laser beam inside the laser cavity system may unintentionally exit through the Slit Lamp output
2021-04-14	Dutch Ophthalmic USA, Inc.	Barcode label extended expiration date. Barcode located at the short side of the outer box shows 2025-10-27 when scanned, while the correct expiry date is 2024-10-01
2016-07-15	Topcon Medical Laser Systems, Inc	Topcon discovered an anomaly with titration, only when EpM is turned on during the titration process. This event may occur if the user turns on EpM, turns off the Landmark (LM) fu
2016-02-01	Laserex Systems Inc.	The Firm discovered that there is a design error which is traceable back to 2012 when a design change on the safety filter optic adaptor was implemented.
2014-12-18	Ziemer Usa Inc	The devices were not shipped with the Starter Kits.
2014-11-04	Bausch & Lomb Inc	A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use.
2014-11-04	Bausch & Lomb Inc	A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use.
2014-11-04	Bausch & Lomb Inc	A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use.
2014-08-15	Lumenis, Inc.	Lumenis initiated a field-correction for the Array Laser Link", GA-0006700 (SN XXYYZZ) because the system may project an erroneous pattern display on the retina, which is different

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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.