YAG laser combination delivery unit (YC-1800)

Basic Information

• Brand Name: YAG laser combination delivery unit (YC-1800)
• Primary DI: 04987669100103
• Version / Model: 17367-0000
• Company Name: NIDEK CO.,LTD.
• Labeler DUNS: 690635461
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-01
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 600424b0-4ea8-4e6f-bc5b-26d31469c64f

Device Description

This combination delivery unit is need to comprise the combination system which enables radiation of the red, yellow, or green laser beam or YAG laser beam while performing the observation with the slit lamp of the YAG laser system. This delivery unit is mounted on the slit lamp of the YAG laser system and connected to the NIDEK Multicolor Laser Photocoagulator MC-500 using the MC connecting cable and fiber optic cable. The combination system allows selection between photocoagulation with the red (647 nm), yellow (577 nm), or green (532 nm) laser beam and YAG laser beam (wavelength: 1064 nm (pulse laser)). In addition, they are selected easily by changing the optical path of the laser beam with the laser select lever, and various kinds of safety devices are integrated into the system to make sure that only the selected laser beam is radiated. This combination delivery unit is the only delivery unit that can be connected both to the NIDEK Multicolor Laser Photocoagulator MC-500 and the NIDEK Ophthalmic YAG Laser System YC-1800.

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	04987669100103	GS1

Customer Contacts

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