WAVELIGHT ALLEGRO TOPOLYZER

GUDID 00380659907678

WAVELIGHT TOPOLYZER VARIO: The WaveLight® Topolyzer™ VARIO and WaveLight® Analyzer II diagnostic devices are measuring instruments intended for use in eye examinations to measure corneal topography. Data from these systems may be exported and used to support refractive surgical procedures with the WaveLight® laser systems.

Alcon Laboratories, Inc.

Corneal topography system
Primary Device ID00380659907678
NIH Device Record Keyd3b78a27-3884-46a9-b725-61399994b48e
Commercial Distribution StatusIn Commercial Distribution
Brand NameWAVELIGHT ALLEGRO TOPOLYZER
Version Model Number8065990767
Company DUNS008018525
Company NameAlcon Laboratories, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com
Phone+1(800)862-5266
Emailweb.masterus@alcon.com

Device Dimensions

Weight70.4 Pound
Weight70.4 Pound
Weight70.4 Pound
Weight70.4 Pound
Weight70.4 Pound
Weight70.4 Pound
Weight70.4 Pound
Weight70.4 Pound
Weight70.4 Pound
Weight70.4 Pound
Weight70.4 Pound
Weight70.4 Pound
Weight70.4 Pound
Weight70.4 Pound
Weight70.4 Pound
Weight70.4 Pound
Weight70.4 Pound
Weight70.4 Pound
Weight70.4 Pound
Weight70.4 Pound

Device Identifiers

Device Issuing AgencyDevice ID
GS100380659907678 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZSExcimer Laser System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2014-09-24

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