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Yellow Laser Photocoagulator

NIDEK CO.,LTD. · Model YLC-500 · UDI-DI 04987669101117

HQF Prescription

510(k) clearances

1,534

Adverse events

Recalls

Facilities

Description

The NIDEK YELLOW LASER PHOTOCOAGULATOR YLC-500 is an ophthalmic laser photocoagulator consisting of a main laser device, a control box, and a power supply. With various types of laser delivery units, it comprises a photocoagulation system. The YLC-500 uses a 577 nm optically pumped semiconductor laser (yellow laser beam) as the treatment beam source. The pumped yellow laser beam (treatment beam) and the aiming beam (635 nm, red laser beam) are fed coaxially into the fiber optic cable. The output terminal of the fiber optic cable is connected to a delivery unit. The laser beam is formed into the desired spot size by the optical system, then the laser beam is emitted to the target area. The delivery units are equipped with a protective filter that protects the physician’s eyes from exposure to the treatment beam reflected from the patient’s eye or contact lens.

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.