Array LaserLink

Basic Information

• Brand Name: Array LaserLink
• Primary DI: 00810096330079
• Version / Model: NA
• Company Name: Lumenis Be, Inc.
• Labeler DUNS: 118292380
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-04-02
• Public Version: 1
• Public Version Date: 2023-04-10
• Public Version Status: New
• Public Device Record Key: ed8506be-ccd9-4462-a8b2-8aa2246ce5fa

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: 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
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	878.4810	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	00810096330079	GS1

Premarket Submissions

Submission Number	Supplement Number
K151109	000