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Endophotocoagulation delivery unit

NIDEK CO.,LTD. · Model 17118-0000 · UDI-DI 04987669100301

GEX Prescription

510(k) clearances

44,035

Adverse events (107 deaths)

201

Recalls

488

Facilities

Description

This Endophotocoagulation Delivery Unit is used for endophotocoagulation. The delivery unit is comprised of an endophoto probe, a relay adapter, a protective filter unit, and a carrying case. The photocoagulation laser system can be easily formed by connecting the endophoto probe to the GREEN LASER PHOTOCOAGULATOR Model GYC-1000 main body and connecting the protective filter to the GYC-1000 main body and the surgical microscope. This photocoagulation laser system enables endophotocoagulation with the green laser (wavelength: 532 nm) while observing the affected area through the surgical microscope. This delivery unit is intended to be used with the protective filter unit attached to surgical microscopes. NIDEK provides following four types of delivery units according to the types of protective filters and the surgical microscopes*1. Before use, check the type of your surgical microscope and delivery unit.

Recalls

Date	Firm	Reason
2026-08-06	Lutronic Corporation	Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud noise during treatment, potentially resulting in patient burn.
2026-05-05	IPG Medical Corporation	Software anomaly that causes a false display of error code 5018.
2026-02-27	Olympus Corporation of the Americas	Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperabl
2026-02-27	Olympus Corporation of the Americas	Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperabl
2026-01-27	Lutronic Corporation	Reports of devices sparking/popping and potentially burning patients.
2025-12-15	LEASEIR TECHNOLOGIES SLU	The console label for affected devices is missing the "DANGER" symbol.
2025-07-22	LUMENIS, LTD.	The potential for unsterilized product within finished product labeled as sterile.
2025-05-06	Olympus Corporation of the Americas	Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or
2025-05-06	Olympus Corporation of the Americas	Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or
2025-05-06	Olympus Corporation of the Americas	Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or

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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.