KXL System

Basic Information

• Brand Name: KXL System
• Primary DI: 00855574003083
• Version / Model: 110-02724
• Company Name: AVEDRO, INC.
• Labeler DUNS: 007274362
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-01-07
• Public Version: 1
• Public Version Date: 2020-01-15
• Public Version Status: New
• Public Device Record Key: 1db953ae-dc36-4c16-8cc8-8dd53616ca5a

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• 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
HMF	Stand, Instrument, Ac-Powered, Ophthalmic	Ophthalmic	886.1860	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57950	Ophthalmic ultraviolet phototherapy system	A mains electricity (AC-powered) mobile device assembly, with a rechargeable battery, designed to deliver a uniform and metered dose of ultraviolet A (UVA) light to the cornea to perform an ophthalmic crosslinking procedure (collagen fibres in the cornea are linked together to stiffen the cornea). It is normally used in a clinical office setting and typically consists of a wheeled central mount that supports the optic head containing the UV source, user control panel, software, and a rechargeable battery. It is typically used to treat corneal disorders such as keratoconus, post laser assisted in situ keratomileusis (LASIK) ectasia, and other post-LASIK disorders.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00855574003083	GS1

Customer Contacts

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