MED RF 4000

Electrosurgical Coagulation For Aesthetic

F Care Systems USA LLC

The following data is part of a premarket notification filed by F Care Systems Usa Llc with the FDA for Med Rf 4000.

Pre-market Notification Details

Device IDK210077
510k NumberK210077
Device Name:MED RF 4000
ClassificationElectrosurgical Coagulation For Aesthetic
Applicant F Care Systems USA LLC 11098 Biscayne BLVD Suite 301 Miami,  FL  33161
ContactPatrick Danciu
CorrespondentPatrick Danciu
F Care Systems USA LLC 11098 Biscayne BLVD Suite 301 Miami,  FL  33161
Product CodeONQ  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-12
Decision Date2021-12-17

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