SCAR 3

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 Scar 3.

Pre-market Notification Details

Device IDK211362
510k NumberK211362
Device Name:SCAR 3
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-03
Decision Date2021-08-25

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