EPLUS SKIN TREATMENT SYSTEM

Powered Laser Surgical Instrument

SYNERON, LTD.

The following data is part of a premarket notification filed by Syneron, Ltd. with the FDA for Eplus Skin Treatment System.

Pre-market Notification Details

Device IDK113868
510k NumberK113868
Device Name:EPLUS SKIN TREATMENT SYSTEM
ClassificationPowered Laser Surgical Instrument
Applicant SYNERON, LTD. 31 HAAVODA ST. Binyamina,  IL 30500
ContactYoram Levy
CorrespondentYoram Levy
SYNERON, LTD. 31 HAAVODA ST. Binyamina,  IL 30500
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-12-30
Decision Date2012-06-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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