Scan slit lamp delivery unit (SL-1800)

Basic Information

• Brand Name: Scan slit lamp delivery unit (SL-1800)
• Primary DI: 04987669100196
• Version / Model: 17482-0000
• 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: f65cf75c-7d25-42c6-8954-b745bf13a362

Device Description

This delivery unit is connected to the NIDEK Multicolor Laser Photocoagulator, Model MC-500 main body to comprise the photocoagulation system and to treat affected areas using the slit lamp, NIDEK SL-1800/SL-1600. A scan slit lamp delivery unit that includes the SL-1800 comprises a photocoagulation system in connection with the MC-500 main body. A scan attachable delivery unit is mainly comprised of a photocoagulation unit and a protective filter unit. They are attached to the NIDEK SL-1800/SL-1600 slit lamp for lasers to comprise a scan slit lamp delivery unit. The comprised scan slit lamp delivery unit is connected to the MC-500 to comprise a photocoagulation system. A photocoagulation system allows the operator to select among photocoagulation with the red (647 nm), yellow (577 nm), or green (532 nm) laser beam and observation of the affected area with the slit lamp.

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	04987669100196	GS1

Customer Contacts

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