VX120 Ophthalmic Diagnostic Device

Tonometer, Ac-powered

LUNEAU SAS

The following data is part of a premarket notification filed by Luneau Sas with the FDA for Vx120 Ophthalmic Diagnostic Device.

Pre-market Notification Details

Device IDK143086
510k NumberK143086
Device Name:VX120 Ophthalmic Diagnostic Device
ClassificationTonometer, Ac-powered
Applicant LUNEAU SAS 1 Avenue De Malaguet Prunay Le Gillon,  FR 28360
ContactIsabelle Durand
CorrespondentIsabelle Durand
LUNEAU SAS 1 Avenue De Malaguet Prunay Le Gillon,  FR 28360
Product CodeHKX  
CFR Regulation Number886.1930 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-10-27
Decision Date2015-06-01
Summary:summary

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