DEKA SMARTXIDE TOUCH

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 Smartxide Touch.

Pre-market Notification Details

Device IDK172362
510k NumberK172362
Device Name:DEKA SMARTXIDE TOUCH
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 Received2017-08-04
Decision Date2017-11-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08057017760726 K172362 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.