OPHTHALMIC YAG LASER SYSTEM

Basic Information

• Brand Name: OPHTHALMIC YAG LASER SYSTEM
• Primary DI: 04987669100073
• Version / Model: YC-1800
• Company Name: NIDEK CO.,LTD.
• Labeler DUNS: 690635461
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-24
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 8140b06d-277a-4c3c-a4c5-29599119c1f1

Device 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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LXS	Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla	Ophthalmic	886.4392	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16947	Ophthalmic solid-state laser system, photodisruption	A mains electricity (AC-powered) device assembly in which input energy is used to excite a glass/crystal rod to emit a high-power laser beam intended to cause a photodisruptive effect in the eye by forming a plasma and generating mechanical shock waves (microexplosions) that destroy tissue when highly focused (e.g., for cataract extraction, posterior capsulotomy). It typically includes a light source and controls/foot-switch and has a built-in slit lamp biomicroscope, or is coupled to a slit lamp or indirect ophthalmoscope by fixed mirrors. It does not include femtosecond pulsing, frequency doubling, or fundus imaging technology.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04987669100073	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]