LEGION System

Unit, Phacofragmentation

Alcon Research, LLC

The following data is part of a premarket notification filed by Alcon Research, Llc with the FDA for Legion System.

Pre-market Notification Details

Device IDK191650
510k NumberK191650
Device Name:LEGION System
ClassificationUnit, Phacofragmentation
Applicant Alcon Research, LLC 6201 South Freeway Fort Worth,  TX  76134
ContactNickerson Hill
CorrespondentNickerson Hill
Alcon Research, LLC 6201 South Freeway Fort Worth,  TX  76134
Product CodeHQC  
CFR Regulation Number886.4670 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-20
Decision Date2019-11-01

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