DEKA SYNCHRO REPLA:Y FAMILY OF LASER SYSTEMS

Powered Laser Surgical Instrument

EL.EN ELECTRONIC ENGINEERING SPA

The following data is part of a premarket notification filed by El.en Electronic Engineering Spa with the FDA for Deka Synchro Repla:y Family Of Laser Systems.

Pre-market Notification Details

Device IDK150516
510k NumberK150516
Device Name:DEKA SYNCHRO REPLA:Y FAMILY OF LASER SYSTEMS
ClassificationPowered Laser Surgical Instrument
Applicant EL.EN ELECTRONIC ENGINEERING SPA VIA BALDANZESE 17 Calenzano,  IT 50041
ContactPaolo Peruzzi
CorrespondentPaolo Peruzzi
EL.EN ELECTRONIC ENGINEERING SPA VIA BALDANZESE 17 Calenzano,  IT 50041
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-03-02
Decision Date2015-04-13
Summary:summary

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