KXL System

GUDID 00855574003007

AVEDRO, INC.

Ophthalmic ultraviolet phototherapy system
Primary Device ID00855574003007
NIH Device Record Key41a977d3-664b-400e-88ce-3db9a7aaf683
Commercial Distribution StatusIn Commercial Distribution
Brand NameKXL System
Version Model Number110-02723
Company DUNS007274362
Company NameAVEDRO, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone844-528-3376
Emailusaorders@avedro.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100855574003007 [Primary]

FDA Product Code

HMFStand, Instrument, Ac-Powered, Ophthalmic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-02-04
Device Publish Date2019-01-02

On-Brand Devices [KXL System]

00855574003007110-02723
00855574003083110-02724

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