VARILUX VISIONPRINT SYSTEM (VPS)

Monitor, Eye Movement

ESSILOR INTL.

The following data is part of a premarket notification filed by Essilor Intl. with the FDA for Varilux Visionprint System (vps).

Pre-market Notification Details

Device IDK033949
510k NumberK033949
Device Name:VARILUX VISIONPRINT SYSTEM (VPS)
ClassificationMonitor, Eye Movement
Applicant ESSILOR INTL. 1301 K STREET, NW Washington,  DC  20005
ContactMarc J Scheineson
CorrespondentMarc J Scheineson
ESSILOR INTL. 1301 K STREET, NW Washington,  DC  20005
Product CodeHLL  
CFR Regulation Number886.1510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-12-19
Decision Date2004-07-02
Summary:summary

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