INTRAcel RF Microneedle System

Electrosurgical, Cutting & Coagulation & Accessories

Jeisys Medical Inc.

The following data is part of a premarket notification filed by Jeisys Medical Inc. with the FDA for Intracel Rf Microneedle System.

Pre-market Notification Details

Device IDK183284
510k NumberK183284
Device Name:INTRAcel RF Microneedle System
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant Jeisys Medical Inc. 307,Daeryung Techno Town 8th, Gamasan-ro 96, Geumcheon-Gu Seoul,  KR 153-775
ContactSugun Lee
CorrespondentParul Chansoria
Elexes Medical Consulting 6494 Tralee Village Dr Dublin,  CA  94568
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral & Plastic Surgery
510k Review PanelGeneral & Plastic Surgery
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-11-26
Decision Date2020-01-15

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