MATRIX RF APPLICATOR

Powered Laser Surgical Instrument

SYNERON MEDICAL LTD.

The following data is part of a premarket notification filed by Syneron Medical Ltd. with the FDA for Matrix Rf Applicator.

Pre-market Notification Details

Device IDK073572
510k NumberK073572
Device Name:MATRIX RF APPLICATOR
ClassificationPowered Laser Surgical Instrument
Applicant SYNERON MEDICAL LTD. P.O. BOX 550 INDUSTRIAL ZONE Yokneam Illit,  IL 20692
ContactYoni Iger
CorrespondentYoni Iger
SYNERON MEDICAL LTD. P.O. BOX 550 INDUSTRIAL ZONE Yokneam Illit,  IL 20692
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-12-19
Decision Date2008-09-17
Summary:summary

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