VX650

Camera, Ophthalmic, Ac-powered

Luneau Technology Operations

The following data is part of a premarket notification filed by Luneau Technology Operations with the FDA for Vx650.

Pre-market Notification Details

Device IDK202221
510k NumberK202221
Device Name:VX650
ClassificationCamera, Ophthalmic, Ac-powered
Applicant Luneau Technology Operations 2 Rue Roger Bonnet Pont-de-l'arche,  FR 27340
ContactYossi Constantinis
CorrespondentYossi Constantinis
Luneau Technology Operations 2 Rue Roger Bonnet Pont-de-l'arche,  FR 27340
Product CodeHKI  
CFR Regulation Number886.1120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-06
Decision Date2021-01-29

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