LenSX Laser System

Ophthalmic Femtosecond Laser

ALCON LABORATORIES, INC.

The following data is part of a premarket notification filed by Alcon Laboratories, Inc. with the FDA for Lensx Laser System.

Pre-market Notification Details

Device IDK161288
510k NumberK161288
Device Name:LenSX Laser System
ClassificationOphthalmic Femtosecond Laser
Applicant ALCON LABORATORIES, INC. 20511 LAKE FOREST DR Lake Forest,  CA  92630
ContactJames Arganda
CorrespondentJames Arganda
ALCON LABORATORIES, INC. 20511 LAKE FOREST DR Lake Forest,  CA  92630
Product CodeOOE  
Subsequent Product CodeHNO
Subsequent Product CodeHQC
CFR Regulation Number886.4390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-05-09
Decision Date2016-11-16
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.