Yellow Laser Photocoagulator

Basic Information

• Brand Name: Yellow Laser Photocoagulator
• Primary DI: 04987669101117
• Version / Model: YLC-500
• Company Name: NIDEK CO.,LTD.
• Labeler DUNS: 690635461
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-04-20
• Public Version: 1
• Public Version Date: 2018-05-21
• Public Version Status: New
• Public Device Record Key: 63d63cc8-6074-451a-8ed2-937a056b2b9f

Device 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.

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
HQF	Laser, Ophthalmic	Ophthalmic	886.4390	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36150	General/multiple surgical frequency-doubled solid-state laser system	A mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod to emit a high-power laser beam, in which the frequency is doubled, intended to precisely cut, excise/vaporize, and coagulate tissues for general surgery, and/or multiple specialized surgical applications (non-dedicated). It includes a light source, delivery/positioning device(s), and controls/foot-switch and may be operated in continuous-wave or pulsed modes.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04987669101117	GS1

Customer Contacts

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