Norlase ECHO photocoagulator

Basic Information

• Brand Name: Norlase ECHO photocoagulator
• Primary DI: 05700002165435
• Version / Model: N007-9200
• Company Name: Norlase ApS
• Labeler DUNS: 305483903
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-15
• Public Version: 1
• Public Version Date: 2022-11-23
• Public Version Status: New
• Public Device Record Key: 4000d6dc-5a45-436e-85ab-f9b76626f4d3

Device Description

The Norlase ECHO Photocoagulator is intended to be used in ophthalmic laser procedures including retinal and macular photocoagulation, iridotomy, and trabeculoplasty

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: Yes
• 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: Yes
• 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
43926	Slit lamp/laser system control interface	An electrically-powered device assembly intended to be connected between a slit lamp and an ophthalmic laser system to facilitate adjustment of laser treatment settings (e.g., laser intensity, spot size and number, pattern parameters, laser beam positioning) during eye laser treatment. It consists of a laser delivery compartment designed to be attached to the slit lamp, a laser power control unit, a touchscreen, and a remote control (e.g., touchpad, 3-D mouse) which duplicates the functions of the laser system remote control.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05700002165435	GS1