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OPHTHALMIC YAG LASER SYSTEM

NIDEK CO.,LTD. · Model YC-1800 · UDI-DI 04987669100073

LXS Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

The ophthalmic YAG laser system YC-1800 emits Nd: YAG laser (hereafter called “YAG laser”) pulse beam by Q-switching. The YC-1800 allows the safe and bloodless treatment of intraocular diseases for outpatients by mechanical disruption caused by energy of the YAG laser pulses. The main purposes of the YC-1800 are posterior capsulotomy for secondary cataract, iridotomy for acute angle-closure glaucoma, and for pupillary membranectomy for traction retinal detachment. The YC-1800 has a slit lamp for observation that includes the YAG laser and its controlling mechanism. The YC-1800 is also equipped with an operation panel and knobs that facilitate operation. The compact and lightweight power supply box is installed separately for lightness and compactness of the system. In addition, a motorized table for the YC-1800 is available optionally.

Recalls

Date	Firm	Reason
2015-03-06	Nidek Inc	Dear Doctor letter and Quick Reference Guide is being sent to users of the YC-1800 to reiterate important safety and cleaning information after complaints of pitting lens that may

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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.